Details for New Drug Application (NDA): 216872
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NDA 216872 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 thirteen 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 216872
| Tradename: | MISOPROSTOL |
| Applicant: | Micro Labs |
| Ingredient: | misoprostol |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 216872
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Oct 17, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | Oct 17, 2022 | TE: | AB | RLD: | No | ||||
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