Details for New Drug Application (NDA): 076095
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NDA 076095 describes MISOPROSTOL, which is a drug marketed by Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc, and is included in four NDAs. It is available from fifteen suppliers. Additional details are available on the MISOPROSTOL profile page.
The generic ingredient in MISOPROSTOL is misoprostol. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
The generic ingredient in MISOPROSTOL is misoprostol. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 076095
| Tradename: | MISOPROSTOL |
| Applicant: | Ani Pharms |
| Ingredient: | misoprostol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076095
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MISOPROSTOL | misoprostol | TABLET;ORAL | 076095 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-745 | 10135-745-60 | 60 TABLET in 1 BOTTLE (10135-745-60) |
| MISOPROSTOL | misoprostol | TABLET;ORAL | 076095 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-745 | 10135-745-62 | 120 TABLET in 1 BOTTLE (10135-745-62) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Jul 10, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | Jul 10, 2002 | TE: | AB | RLD: | No | ||||
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