Details for New Drug Application (NDA): 091667
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NDA 091667 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 twelve 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 091667
| Tradename: | MISOPROSTOL |
| Applicant: | Novel Labs Inc |
| Ingredient: | misoprostol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091667
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MISOPROSTOL | misoprostol | TABLET;ORAL | 091667 | ANDA | Novel Laboratories, Inc. | 40032-160 | 40032-160-06 | 60 TABLET in 1 BOTTLE (40032-160-06) |
| MISOPROSTOL | misoprostol | TABLET;ORAL | 091667 | ANDA | Novel Laboratories, Inc. | 40032-160 | 40032-160-12 | 120 TABLET in 1 BOTTLE (40032-160-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Jul 25, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | Jul 25, 2012 | TE: | RLD: | No | |||||
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