Details for New Drug Application (NDA): 203139
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The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 203139
Tradename: | MEGESTROL ACETATE |
Applicant: | Twi Pharms |
Ingredient: | megestrol acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203139
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139 | ANDA | TWi Pharmaceuticals, Inc. | 24979-041 | 24979-041-13 | 150 mL in 1 BOTTLE (24979-041-13) |
MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139 | ANDA | Proficient Rx LP | 71205-943 | 71205-943-15 | 150 mL in 1 BOTTLE (71205-943-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 125MG/ML | ||||
Approval Date: | Aug 27, 2014 | TE: | AB | RLD: | No |
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