Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076455
Company: DURAMED PHARMS BARR

Products on ANDA 076455

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOGESTREL; ETHINYL	DESOGESTREL; ETHINYL ESTRADIOL	0.125MG/0.025MG	Tablet; Oral	Prescription	None	No	No
DESOGESTREL; ETHINYL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG/0.025MG	Tablet; Oral	Prescription	None	No	No
VELIVET	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076455

DESOGESTREL; ETHINYL

There are no Therapeutic Equivalents.

VELIVET

TABLET;ORAL-28; 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLESSA	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	Yes	AB	021090	ASPEN GLOBAL INC
VELIVET	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	No	AB	076455	DURAMED PHARMS BARR