Details for New Drug Application (NDA): 210201
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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 210201
Tradename: | MISOPROSTOL |
Applicant: | Acq Pharma |
Ingredient: | misoprostol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 210201
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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