Details for New Drug Application (NDA): 074826
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NDA 074826 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 three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the estazolam profile page.
Summary for 074826
| Tradename: | ESTAZOLAM |
| Applicant: | Novitium Pharma |
| Ingredient: | estazolam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074826
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTAZOLAM | estazolam | TABLET;ORAL | 074826 | ANDA | Novitium Pharma LLC | 70954-480 | 70954-480-10 | 100 TABLET in 1 BOTTLE (70954-480-10) |
| ESTAZOLAM | estazolam | TABLET;ORAL | 074826 | ANDA | Novitium Pharma LLC | 70954-481 | 70954-481-10 | 100 TABLET in 1 BOTTLE (70954-481-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 3, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 3, 1997 | TE: | AB | RLD: | No | ||||
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