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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074538
Company: DR REDDYS LABS SA

Products on ANDA 074538

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074538.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
02/22/2022	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
04/03/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf
02/10/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/08/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074538

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf

Therapeutic Equivalents for ANDA 074538

TRIVORA-21

There are no Therapeutic Equivalents.

TRIVORA-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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