Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075288
Company: DR REDDYS LABS SA

Products on ANDA 075288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOW-OGESTREL-21	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-21	Discontinued	None	No	No
LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75288ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075288_norgestrel-and-ethinyl-estradiol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/28/2022	SUPPL-23	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-21	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/24/2005	SUPPL-8	Labeling		Label is not available on this site.

Labels for ANDA 075288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075288

LOW-OGESTREL-21

There are no Therapeutic Equivalents.

LOW-OGESTREL-28

TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075840	DURAMED PHARMS BARR
ELINEST	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	091105	NOVAST LABS LTD
LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075288	DR REDDYS LABS SA
TURQOZ	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	202980	LUPIN LTD