Details for New Drug Application (NDA): 079102
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NDA 079102 describes ALTAVERA, which is a drug marketed by Xiromed and is included in one NDA. It is available from two suppliers. Additional details are available on the ALTAVERA profile page.
The generic ingredient in ALTAVERA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in ALTAVERA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 079102
| Tradename: | ALTAVERA |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079102
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALTAVERA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 079102 | ANDA | Bryant Ranch Prepack | 63629-2343 | 63629-2343-1 | 3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK |
| ALTAVERA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 079102 | ANDA | Xiromed, LLC. | 70700-116 | 70700-116-85 | 3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | Aug 3, 2010 | TE: | AB | RLD: | No | ||||
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