Active ingredient
Estazolam
6 finished FDA listings contain Estazolam as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ESTAZOLAM
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 1 mg/1 · 2 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4077
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 |
|---|---|---|---|
| ANDA 074826 | NOVITIUM PHARMA | 1997-07-03 | 2 |
| ANDA 074921 | DR REDDYS LABS SA | 1997-07-10 | 2 |
| ANDA 074818 | WATSON LABS | 1997-08-19 | 2 |
Official labeling on DailyMed
- ESTAZOLAM TABLET [ACTAVIS PHARMA, INC.] · version 23 · 2025-06-26
- ESTAZOLAM TABLET [DR. REDDY'S LABRATORIES INC.] · version 1 · 2024-02-15
- ESTAZOLAM TABLET [NOVITIUM PHARMA LLC] · version 3 · 2022-11-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.