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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 three 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. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 076455

Duramed Pharms Barr
desogestrel; ethinyl estradiol

Suppliers and Packaging for NDA: 076455

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
desogestrel; ethinyl estradiol
TABLET;ORAL-28 076455 ANDA Mayne Pharma Inc. 51862-238 51862-238-03 3 POUCH in 1 CARTON (51862-238-03) > 1 BLISTER PACK in 1 POUCH (51862-238-01) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
Approval Date:Feb 24, 2004TE:ABRLD:No

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