An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 011722
Company: NOSTRUM LABS INC

Products on NDA 011722

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENUATE	DIETHYLPROPION HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 011722

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/1959	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2004	SUPPL-29	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
07/14/2000	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
05/06/1999	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.
02/10/1984	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/06/1984	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.
08/03/1983	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/18/1982	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/31/1979	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/1978	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/23/1976	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/12/1976	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 011722

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2004	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf

Top