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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012546
Company: NOSTRUM LABS INC

Products on NDA 012546

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENUATE DOSPAN	DIETHYLPROPION HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012546

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1960	ORIG-1	Approval	Type 2 - New Active Ingredient	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
12/19/2013	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
09/03/2004	SUPPL-32	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11722s029,12546s032ltr.pdf
04/16/2002	SUPPL-31	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/09/2000	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
05/06/1999	SUPPL-29	Labeling		Label is not available on this site.
02/02/1998	SUPPL-27	Labeling		Label is not available on this site.
02/02/1998	SUPPL-25	Labeling		Label is not available on this site.
07/21/1988	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/03/1986	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/22/1985	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/23/1983	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/08/1983	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/1982	SUPPL-18	Labeling		Label is not available on this site.
06/17/1988	SUPPL-17	Labeling		Label is not available on this site.
10/18/1982	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/06/1979	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/1978	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/27/1976	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/24/1975	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 012546

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2004	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf

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