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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075809
Company: DURAMED PHARMS BARR

Products on ANDA 075809

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENPRESSE-21	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-21	Discontinued	None	No	No
ENPRESSE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075809

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2001	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
04/29/2022	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
01/28/2022	SUPPL-27	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/28/2022	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
06/19/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
05/21/2002	SUPPL-3	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
03/12/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075809

ENPRESSE-21

There are no Therapeutic Equivalents.

ENPRESSE-28

TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENPRESSE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	075809	DURAMED PHARMS BARR
LEVONEST	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	090719	NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	200248	LUPIN
TRIVORA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	074538	DR REDDYS LABS SA

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