Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009193
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COGENTIN BENZTROPINE MESYLATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
COGENTIN BENZTROPINE MESYLATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
COGENTIN BENZTROPINE MESYLATE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
03/05/1954 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2009 SUPPL-39 Labeling

Label is not available on this site.

03/13/2009 SUPPL-38 Labeling

Label is not available on this site.

05/22/2001 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
04/15/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/01/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-34 Labeling

Label is not available on this site.

03/13/2009 SUPPL-33 Labeling

Label is not available on this site.

04/08/1988 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/25/1986 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1986 SUPPL-29 Labeling

Label is not available on this site.

09/13/1984 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1984 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1982 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/03/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-24 Labeling

Label is not available on this site.

06/02/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1979 SUPPL-21 Labeling

Label is not available on this site.

04/19/1979 SUPPL-20 Labeling

Label is not available on this site.

03/13/2009 SUPPL-19 Labeling

Label is not available on this site.

05/01/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1977 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1977 SUPPL-16 Labeling

Label is not available on this site.

03/13/2009 SUPPL-15 Labeling

Label is not available on this site.

01/15/1975 SUPPL-14 Labeling

Label is not available on this site.

07/01/1974 SUPPL-10 Unspecified

Label is not available on this site.

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