Active ingredient
Pomalidomide
47 finished FDA listings contain Pomalidomide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- POMALIDOMIDE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 12
- Strengths listed
- 1 mg/1 · 2 mg/1 · 3 mg/1 · 4 mg/1
- Brand names in FDA listings
- Pomalyst
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1369713
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 204026 | BRISTOL | 2013-02-08 | 4 |
| ANDA 210249 | EUGIA PHARMA | 2020-10-30 | 4 |
| ANDA 210111 | BRECKENRIDGE | 2020-10-30 | 8 |
| ANDA 209956 | TEVA PHARMS USA | 2022-05-04 | 4 |
| ANDA 210164 | APOTEX | 2024-06-11 | 4 |
| ANDA 210236 | HETERO LABS LTD V | 2024-09-26 | 4 |
| ANDA 220741 | SANDOZ | 2026-08-31 | 4 |
| ANDA 210232 | SPIL | 2026-08-31 | 4 |
| ANDA 213234 | DR REDDYS | 2026-08-31 | 4 |
| ANDA 219718 | CIPLA | 2026-08-31 | 4 |
| ANDA 210245 | MSN | 2026-09-02 | 3 |
Official labeling on DailyMed
- POMALIDOMIDE CAPSULE POMALIDOMIDE CAPSULE [SANDOZ INC] · version 1 · 2026-09-02
- POMALIDOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-09-02
- POMALIDOMIDE CAPSULE [CIPLA USA INC.] · version 1 · 2026-09-01
- POMALIDOMIDE CAPSULE [DR. REDDY'S LABORATORIES INC.] · version 10 · 2026-09-01
- POMALIDOMIDE CAPSULE [TEVA PHARMACEUTICALS, INC.] · version 3 · 2026-08-21
- POMALIDOMIDE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 10 · 2026-03-18
- POMALIDOMIDE CAPSULE [APOTEX CORP.] · version 2 · 2026-03-12
- POMALIDOMIDE (POMALIDOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2026-03-06
- POMALIDOMIDE CAPSULE [AUROBINDO PHARMA LIMITED] · version 1 · 2026-02-03
- POMALIDOMIDE CAPSULE [NATCO PHARMA LIMITED] · version 1 · 2025-11-19
- POMALYST (POMALIDOMIDE) CAPSULE [CELGENE CORPORATION] · version 26 · 2025-05-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.