Details for New Drug Application (NDA): 076455
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NDA 076455 describes VELIVET, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the VELIVET profile page.
The generic ingredient in VELIVET is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in VELIVET is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 076455
| Tradename: | VELIVET |
| Applicant: | Duramed Pharms Barr |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076455
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELIVET | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 076455 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9051 | 0555-9051-67 | 3 POUCH in 1 CARTON (0555-9051-67) / 1 BLISTER PACK in 1 POUCH (0555-9051-79) / 1 KIT in 1 BLISTER PACK |
| VELIVET | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 076455 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1775 | 53002-1775-1 | 1 KIT in 1 BLISTER PACK (53002-1775-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | ||||
| Approval Date: | Feb 24, 2004 | TE: | AB | RLD: | No | ||||
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