Details for New Drug Application (NDA): 091667
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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 091667
Tradename: | MISOPROSTOL |
Applicant: | Novel Labs Inc |
Ingredient: | misoprostol |
Patents: | 0 |
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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