Active ingredient
Atazanavir
16 finished FDA listings contain Atazanavir as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ATAZANAVIR SULFATE
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Powder
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1 · 150 mg/1 · 200 mg/1 · 300 mg/1 · 50 mg/1
- Brand names in FDA listings
- Atazanavir Sulfate, Reyataz
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 343047
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 021567 | BRISTOL MYERS SQUIBB | 2003-06-20 | 2 |
| ANDA 091673 | TEVA PHARMS USA | 2014-04-22 | 3 |
| NDA 206352 | BRISTOL MYERS SQUIBB | 2014-06-02 | 1 |
| ANDA 204806 | AUROBINDO PHARMA | 2018-06-25 | 4 |
| ANDA 212579 | LAURUS | 2021-04-30 | 3 |
| ANDA 212278 | HETERO LABS LTD III | 2022-02-02 | 3 |
Official labeling on DailyMed
- ATAZANAVIR SULFATE (ATAZANAVIR) CAPSULE [AUROBINDO PHARMA LIMITED] · version 8 · 2025-09-10
- REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] · version 37 · 2025-07-18
- ATAZANAVIR CAPSULE [LAURUS LABS LIMITED] · version 4 · 2025-06-03
- ATAZANAVIR SULFATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 14 · 2025-04-03
- ATAZANAVIR (ATAZANAVIR) CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2025-03-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.