An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 LTD
MYZILRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	077502	VINTAGE PHARMS LLC
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

Top