Data / Drug companies / New drug applications (NDA)
Companies that list new drug applications (nda) products: 1,036 companies and 7,381 products in the FDA NDC directory
The FDA National Drug Code Directory lists 7,381 products that are drugs marketed under a new drug application (NDA) from 1,036 companies. The ten largest listers hold 16.8% of them, and the newest started marketing on November 2, 2026.
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- Companies
- 1,036
- Products
- 7,381
- Drugs by generic name
- 1,708
- Main marketing category
- New drug applications (NDA)
Companies with the most new drug applications (nda)
Ranked by number of products in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Baxter Healthcare Corporation | 214 | injection, solution; injection | New drug applications (NDA) | October 19, 2026 |
| A-S Medication Solutions | 150 | tablet, film coated; injection, solution | New drug applications (NDA) | April 27, 2026 |
| Novartis Pharmaceuticals Corporation | 143 | tablet, film coated; tablet | New drug applications (NDA) | September 30, 2025 |
| Hospira, Inc. | 138 | injection, solution; injection, solution, concentrate | New drug applications (NDA) | March 16, 2026 |
| Fresenius Kabi USA, LLC | 127 | injection, solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | March 13, 2025 |
| Pfizer Laboratories Div Pfizer Inc | 112 | tablet, film coated; capsule | New drug applications (NDA) | January 5, 2026 |
| HF Acquisition Co LLC, DBA HealthFirst | 110 | injection, solution; injection | New drug applications (NDA) | March 16, 2026 |
| Eli Lilly and Company | 89 | injection, solution; tablet, film coated | New drug applications (NDA) | April 1, 2026 |
| B. Braun Medical Inc. | 79 | injection, solution; injection | New drug applications (NDA) | October 1, 2026 |
| Viatris Specialty LLC | 77 | tablet, film coated; capsule | New drug applications (NDA) | September 28, 2026 |
| GlaxoSmithKline LLC | 71 | tablet, film coated; powder | New drug applications (NDA) | October 20, 2026 |
| Pharmacia & Upjohn Company LLC | 71 | injection, solution; injection, powder, for solution | New drug applications (NDA) | December 30, 2024 |
| Bausch Health US LLC | 70 | tablet, extended release; tablet | New drug applications (NDA) | October 20, 2023 |
| AbbVie Inc. | 65 | tablet; kit | New drug applications (NDA) | September 25, 2026 |
| Bayer HealthCare Pharmaceuticals Inc. | 63 | injection; tablet, film coated | New drug applications (NDA) | June 12, 2026 |
| Janssen Pharmaceuticals, Inc. | 63 | tablet, film coated; tablet, extended release | New drug applications (NDA) | December 1, 2021 |
| AstraZeneca Pharmaceuticals LP | 56 | tablet, film coated; tablet, film coated, extended release | New drug applications (NDA) | September 4, 2026 |
| Merck Sharp & Dohme LLC | 55 | tablet, film coated; injection, solution | New drug applications (NDA) | July 15, 2026 |
| Icu Medical Inc. | 53 | injection, solution; irrigant | New drug applications (NDA) | October 1, 2021 |
| Organon LLC | 50 | tablet, film coated; tablet | New drug applications (NDA) | December 1, 2025 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 49 | tablet, film coated; tablet, extended release | New drug applications (NDA) | October 7, 2025 |
| Gilead Sciences, Inc. | 49 | tablet, film coated; tablet | New drug applications (NDA) | October 31, 2026 |
| Henry Schein, Inc. | 49 | injection, solution; injection | New drug applications (NDA) | June 24, 2026 |
| Hikma Pharmaceuticals USA Inc. | 48 | injection; injection, powder, for solution | New drug applications (NDA) | October 22, 2026 |
| Roberts Oxygen Company, Inc. | 44 | gas | New drug applications (NDA) | November 17, 2025 |
| Fenwal, Inc. | 42 | solution; kit | New drug applications (NDA) | October 3, 2025 |
| Hikma Pharmaceuticals USA Inc. | 42 | injection; injection, solution | New drug applications (NDA) | August 29, 2025 |
| H2-Pharma, LLC | 41 | tablet; tablet, film coated | New drug applications (NDA) | August 18, 2025 |
| Haleon US Holdings LLC | 41 | tablet, coated; suspension | New drug applications (NDA) | January 15, 2025 |
| Medical Purchasing Solutions, LLC | 41 | injection, solution; injection | New drug applications (NDA) | August 19, 2024 |
| Cardinal Health 107, LLC | 40 | tablet, film coated; injection, solution | New drug applications (NDA) | May 12, 2026 |
| Par Health USA, LLC | 40 | injection; injection, powder, lyophilized, for solution | New drug applications (NDA) | October 27, 2025 |
| Azurity Pharmaceuticals, Inc. | 38 | solution; tablet | New drug applications (NDA) | April 17, 2026 |
| Lil' Drug Store Products, Inc. | 38 | tablet, film coated; tablet | New drug applications (NDA) | July 10, 2024 |
| Vanda Pharmaceuticals Inc. | 38 | tablet; kit | New drug applications (NDA) | July 1, 2026 |
| Allergan, Inc. | 37 | tablet; tablet, film coated | New drug applications (NDA) | March 24, 2023 |
| Ibsa Pharma Inc. | 36 | capsule; solution | New drug applications (NDA) | February 15, 2026 |
| E.r. Squibb & Sons, L.L.C. | 35 | tablet; tablet, film coated | New drug applications (NDA) | August 13, 2026 |
| Haleon US Holdings LLC | 34 | gum, chewing; lozenge | New drug applications (NDA) | April 1, 2026 |
| Sandoz Inc | 34 | patch, extended release; capsule, extended release | New drug applications (NDA) | July 7, 2017 |
| United Therapeutics Corporation | 34 | kit; inhalant | New drug applications (NDA) | November 7, 2025 |
| Otsuka America Pharmaceutical, Inc. | 33 | tablet; kit | New drug applications (NDA) | October 24, 2026 |
| WG Critical Care, LLC | 32 | injection, solution; injection | New drug applications (NDA) | March 21, 2025 |
| Avyxa Pharma, LLC | 31 | injection; injection, solution | New drug applications (NDA) | October 29, 2026 |
| Bausch & Lomb Incorporated | 31 | solution/ drops; solution | New drug applications (NDA) | March 19, 2026 |
| Cosette Pharmaceuticals, Inc. | 31 | tablet, film coated; tablet, coated | New drug applications (NDA) | April 1, 2026 |
| Ani Pharmaceuticals, Inc. | 30 | tablet; capsule, extended release | New drug applications (NDA) | February 28, 2025 |
| Takeda Pharmaceuticals America, Inc. | 30 | tablet, film coated; tablet | New drug applications (NDA) | February 9, 2024 |
| Bracco Diagnostics Inc | 29 | injection, solution; injection | New drug applications (NDA) | January 1, 2026 |
| Novo Nordisk | 29 | injection, solution; tablet | New drug applications (NDA) | April 27, 2026 |
| Remedyrepack Inc. | 29 | injection, solution; tablet, film coated | New drug applications (NDA) | August 23, 2026 |
| Takeda Pharmaceuticals America, Inc. | 29 | capsule, extended release; tablet, extended release | New drug applications (NDA) | December 14, 2018 |
| ProPharma Distribution | 28 | injection, solution; injection | New drug applications (NDA) | January 30, 2023 |
| Validus Pharmaceuticals LLC | 28 | tablet; tablet, sugar coated | New drug applications (NDA) | October 1, 2026 |
| Hikma Pharmaceuticals USA Inc. | 27 | tablet; capsule, gelatin coated | New drug applications (NDA) | August 16, 2026 |
| Matheson Tri-Gas, Inc. | 27 | gas | New drug applications (NDA) | January 1, 1987 |
| Ucb, Inc. | 27 | tablet, film coated; patch, extended release | New drug applications (NDA) | March 1, 2026 |
| Fresenius Kabi USA, LLC | 26 | injection, solution; emulsion | New drug applications (NDA) | July 29, 2026 |
| ViiV Healthcare Company | 26 | tablet, film coated; kit | New drug applications (NDA) | January 21, 2025 |
| Astellas Pharma US, Inc. | 25 | tablet; capsule | New drug applications (NDA) | May 16, 2023 |
| Kenvue Brands LLC | 25 | suspension; tablet, chewable | New drug applications (NDA) | June 2, 2025 |
| Allergan, Inc. | 24 | solution/ drops; emulsion | New drug applications (NDA) | December 1, 2021 |
| Almatica Pharma LLC | 24 | capsule; tablet, film coated | New drug applications (NDA) | July 1, 2026 |
| Celgene Corporation | 24 | capsule; tablet, film coated | New drug applications (NDA) | September 1, 2020 |
| Curium US LLC | 24 | injection, solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | September 14, 2026 |
| Eisai Inc. | 24 | tablet, film coated; tablet | New drug applications (NDA) | April 7, 2020 |
| Sportpharm LLC | 24 | injection, solution; spray | New drug applications (NDA) | January 9, 2026 |
| Xttrium Laboratories, Inc. | 24 | solution; liquid | New drug applications (NDA) | December 14, 2023 |
| Bayer HealthCare LLC. | 23 | tablet; tablet, chewable | New drug applications (NDA) | May 22, 2024 |
| Walgreen Company | 23 | capsule, liquid filled; patch, extended release | New drug applications (NDA) | June 19, 2026 |
| Waylis Therapeutics LLC | 23 | tablet, film coated; capsule | New drug applications (NDA) | September 11, 2025 |
| American Regent, Inc. | 22 | injection, solution; injection | New drug applications (NDA) | August 19, 2025 |
| Janssen Products, LP | 22 | tablet, film coated; tablet | New drug applications (NDA) | February 27, 2026 |
| Actelion Pharmaceuticals US, Inc. | 21 | tablet, coated; tablet, film coated | New drug applications (NDA) | May 23, 2026 |
| Baxter Healthcare Company | 21 | injection; injection, powder, for solution | New drug applications (NDA) | December 15, 2022 |
| Bayer HealthCare LLC. | 21 | tablet; capsule, liquid filled | New drug applications (NDA) | April 4, 2023 |
| U.S. Pharmaceuticals | 21 | tablet, film coated; capsule, liquid filled | New drug applications (NDA) | July 9, 2024 |
| Amgen, Inc | 20 | tablet, coated; kit | New drug applications (NDA) | August 29, 2025 |
| Chattem, Inc. | 20 | tablet, film coated; tablet | New drug applications (NDA) | May 1, 2026 |
| Pfizer Laboratories Div Pfizer Inc | 20 | tablet; injection, suspension | New drug applications (NDA) | May 25, 2001 |
| Proficient Rx LP | 20 | tablet; tablet, film coated | New drug applications (NDA) | May 7, 2019 |
| Roerig | 20 | injection, powder, lyophilized, for solution; capsule | New drug applications (NDA) | February 20, 2024 |
| SpecGx LLC | 20 | capsule; concentrate | New drug applications (NDA) | June 1, 2015 |
| Vertex Pharmaceuticals Incorporated | 20 | granule; kit | New drug applications (NDA) | January 30, 2025 |
| Alcon Laboratories, Inc. | 19 | solution; solution/ drops | New drug applications (NDA) | October 16, 2026 |
| Knoa Pharma LLC | 19 | tablet, film coated, extended release; tablet, extended release | New drug applications (NDA) | August 7, 2025 |
| Legacy Pharma USA Inc. | 19 | tablet; capsule | New drug applications (NDA) | September 10, 2026 |
| Takeda Pharmaceuticals America, Inc. | 19 | tablet, film coated; kit | New drug applications (NDA) | August 28, 2026 |
| Alvogen Inc. | 18 | tablet; injection, solution | New drug applications (NDA) | June 6, 2025 |
| Amneal Pharmaceuticals LLC | 18 | capsule, extended release; granule | New drug applications (NDA) | May 16, 2025 |
| Aphena Pharma Solutions - Tennessee, LLC | 18 | tablet, film coated; capsule | New drug applications (NDA) | June 21, 2019 |
| Civica, Inc. | 18 | injection; injection, powder, lyophilized, for solution | New drug applications (NDA) | August 18, 2026 |
| Covis Pharma US, Inc | 18 | injection, solution; tablet, film coated, extended release | New drug applications (NDA) | October 29, 2019 |
| Genentech, Inc. | 18 | tablet, film coated; capsule | New drug applications (NDA) | May 30, 2025 |
| Mylan Institutional LLC | 18 | injection, solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | April 15, 2020 |
| Noven Therapeutics, LLC | 18 | film, extended release; patch, extended release | New drug applications (NDA) | May 15, 2023 |
| Advanz Pharma (US) Corp. | 17 | tablet; capsule | New drug applications (NDA) | May 19, 2025 |
| Amneal Pharmaceuticals LLC | 17 | injection; kit | New drug applications (NDA) | April 18, 2025 |
| GVS TM Inc | 17 | solution | New drug applications (NDA) | June 24, 2026 |
| Preferred Pharmaceuticals Inc. | 17 | tablet; cream | New drug applications (NDA) | August 20, 2026 |
Drugs most often listed
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.