Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012546
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENUATE DOSPAN DIETHYLPROPION HYDROCHLORIDE 75MG TABLET, EXTENDED RELEASE;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
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.

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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