Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077681
Company: DR REDDYS LABS SA

• Label 2

Products on ANDA 077681

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	AB2	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077681

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2006	ORIG-1	Approval			Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/14/2017	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 077681

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf

Therapeutic Equivalents for ANDA 077681

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LESSINA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB2	075803	BARR
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB2	077681	DR REDDYS LABS SA