Details for New Drug Application (NDA): 078033
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The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.
Summary for 078033
Tradename: | OXANDROLONE |
Applicant: | Upsher Smith Labs |
Ingredient: | oxandrolone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 078033
Suppliers and Packaging for NDA: 078033
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXANDROLONE | oxandrolone | TABLET;ORAL | 078033 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0272 | 0245-0272-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0272-01) / 1 TABLET in 1 BLISTER PACK (0245-0272-89) |
OXANDROLONE | oxandrolone | TABLET;ORAL | 078033 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0272 | 0245-0272-06 | 60 TABLET in 1 BOTTLE (0245-0272-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 22, 2007 | TE: | RLD: | No |
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