Details for New Drug Application (NDA): 200271
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The generic ingredient in HYDROXYPROGESTERONE CAPROATE is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
Summary for 200271
Tradename: | HYDROXYPROGESTERONE CAPROATE |
Applicant: | Aspen Global Inc |
Ingredient: | hydroxyprogesterone caproate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200271
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 200271 | ANDA | Mylan Institutional LLC | 67457-886 | 67457-886-05 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-886-05) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 1250MG/5ML (250MG/ML) | ||||
Approval Date: | Aug 24, 2015 | TE: | RLD: | No |
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