Details for New Drug Application (NDA): 077827
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NDA 077827 describes OXANDROLONE, which is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher Smith Labs, and is included in five NDAs. It is available from one supplier. Additional details are available on the OXANDROLONE profile page.
The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxandrolone profile page.
The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxandrolone profile page.
Summary for 077827
| Tradename: | OXANDROLONE |
| Applicant: | Par Pharm |
| Ingredient: | oxandrolone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 077827
Suppliers and Packaging for NDA: 077827
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXANDROLONE | oxandrolone | TABLET;ORAL | 077827 | ANDA | Par Pharmaceutical, Inc. | 49884-301 | 49884-301-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49884-301-01) |
| OXANDROLONE | oxandrolone | TABLET;ORAL | 077827 | ANDA | Par Pharmaceutical, Inc. | 49884-302 | 49884-302-02 | 60 TABLET in 1 BOTTLE, PLASTIC (49884-302-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jun 22, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 22, 2007 | TE: | RLD: | No | |||||
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