Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006773
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML ELIXIR;ORAL Discontinued None No No
ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No 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
05/13/1949 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2003 SUPPL-36 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06773slr036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/006773_S036_ARTANE.pdf
01/28/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/02/1997 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/02/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/19/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/19/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/17/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1993 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1987 SUPPL-23 Labeling

Label is not available on this site.

07/24/1987 SUPPL-22 Labeling

Label is not available on this site.

06/26/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1976 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1975 SUPPL-10 Labeling

Label is not available on this site.

01/27/1976 SUPPL-9 Unspecified

Label is not available on this site.

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