Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011722
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENUATE DIETHYLPROPION HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None Yes No
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.

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

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