Details for New Drug Application (NDA): 076095
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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 076095
Tradename: | MISOPROSTOL |
Applicant: | Ani Pharms |
Ingredient: | misoprostol |
Patents: | 0 |
Suppliers and Packaging for NDA: 076095
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MISOPROSTOL | misoprostol | TABLET;ORAL | 076095 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-745 | 10135-745-60 | 60 TABLET in 1 BOTTLE (10135-745-60) |
MISOPROSTOL | misoprostol | TABLET;ORAL | 076095 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-745 | 10135-745-62 | 120 TABLET in 1 BOTTLE (10135-745-62) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
Approval Date: | Jul 10, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
Approval Date: | Jul 10, 2002 | TE: | AB | RLD: | No |
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