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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075803
Company: BARR

Products on ANDA 075803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LESSINA-21	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-21	Discontinued	None	No	No
LESSINA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75803_Levonorgestrel And Ethinyl Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75803.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075803_levonorgestrel-ethinyl_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-34	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-29	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/27/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/2002	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/30/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 075803

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75803_Levonorgestrel And Ethinyl Estradiol_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075803

LESSINA-21

There are no Therapeutic Equivalents.

LESSINA-28

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

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