Details for New Drug Application (NDA): 079064
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NDA 079064 describes INTROVALE, which is a drug marketed by Xiromed and is included in one NDA. It is available from one supplier. Additional details are available on the INTROVALE profile page.
The generic ingredient in INTROVALE 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 INTROVALE 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 079064
| Tradename: | INTROVALE |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079064
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INTROVALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 079064 | ANDA | Xiromed, LLC. | 70700-117 | 70700-117-87 | 1 BLISTER PACK in 1 CARTON (70700-117-87) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | Sep 27, 2010 | TE: | AB | RLD: | No | ||||
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