Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073115
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;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
08/23/1991 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
10/07/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/30/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-1 Labeling

Label is not available on this site.

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