Details for New Drug Application (NDA): 075796

NDA 075796 describes AVIANE-28, 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 AVIANE-28 profile page.

The generic ingredient in AVIANE-28 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 075796

Tradename:	AVIANE-28
Applicant:	Duramed Pharms Barr
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Suppliers and Packaging for NDA: 075796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AVIANE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	075796	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9045	0555-9045-58	6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK
AVIANE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	075796	ANDA	Proficient Rx LP	63187-889	63187-889-28	1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.02MG;0.1MG
Approval Date:	Apr 30, 2001	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.02MG;0.1MG
Approval Date:	Apr 30, 2001	TE:		RLD:	No

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