Details for New Drug Application (NDA): 210201
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NDA 210201 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 fourteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 210201
| Tradename: | MISOPROSTOL |
| Applicant: | Acq Pharma |
| Ingredient: | misoprostol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MISOPROSTOL | misoprostol | TABLET;ORAL | 210201 | ANDA | GenBioPro, Inc. | 43393-200 | 43393-200-48 | 12 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK |
| MISOPROSTOL | misoprostol | TABLET;ORAL | 210201 | ANDA | GenBioPro, Inc. | 43393-200 | 43393-200-60 | 60 TABLET in 1 BOTTLE (43393-200-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Jul 2, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | Jul 2, 2019 | TE: | RLD: | No | |||||
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