Details for New Drug Application (NDA): 074921
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NDA 074921 describes ESTAZOLAM, which is a drug marketed by Dr Reddys Labs Sa, Novitium Pharma, and Watson Labs, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ESTAZOLAM profile page.
The generic ingredient in ESTAZOLAM is estazolam. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estazolam profile page.
The generic ingredient in ESTAZOLAM is estazolam. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estazolam profile page.
Summary for 074921
| Tradename: | ESTAZOLAM |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | estazolam |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074921
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTAZOLAM | estazolam | TABLET;ORAL | 074921 | ANDA | Mayne Pharma | 51862-073 | 51862-073-01 | 100 TABLET in 1 BOTTLE, PLASTIC (51862-073-01) |
| ESTAZOLAM | estazolam | TABLET;ORAL | 074921 | ANDA | Mayne Pharma | 51862-074 | 51862-074-01 | 100 TABLET in 1 BOTTLE, PLASTIC (51862-074-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 10, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 10, 1997 | TE: | AB | RLD: | No | ||||
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