Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075406
Company: WATSON LABS

Products on ANDA 075406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OGESTREL 0.5/50-21	ETHINYL ESTRADIOL; NORGESTREL	0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL-21	Discontinued	None	No	No
OGESTREL 0.5/50-28	ETHINYL ESTRADIOL; NORGESTREL	0.05MG;0.5MG	TABLET;ORAL-28	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/75406ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/19/2017	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/04/2008	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/075406s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075406Orig1s016ltr.pdf
10/04/2006	SUPPL-11	Labeling		Label is not available on this site.

Labels for ANDA 075406

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2008	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/075406s016lbl.pdf