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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018405
Company: DURAMED RES

Products on NDA 018405

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AYGESTIN	NORETHINDRONE ACETATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018405

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/1982	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2007	SUPPL-23	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018405s023_ltr.pdf
11/06/2002	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/12/2000	SUPPL-16	Labeling		Label is not available on this site.
11/11/1997	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/20/1990	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/1991	SUPPL-12	Labeling		Label is not available on this site.
12/20/1988	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/28/1987	SUPPL-10	Labeling		Label is not available on this site.
08/26/1987	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/1986	SUPPL-7	Labeling		Label is not available on this site.
11/08/1983	SUPPL-3	Labeling		Label is not available on this site.

Labels for NDA 018405

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2007	SUPPL-23	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf

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