Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074641
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET;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
08/02/1996 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
07/25/2001 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/25/2001 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/31/1999 SUPPL-4 Labeling

Label is not available on this site.

09/18/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/08/1998 SUPPL-2 Labeling

Label is not available on this site.

07/11/1997 SUPPL-1 Labeling

Label is not available on this site.

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