Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072655
Company: G AND W LABS INC
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
10/30/1990 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
07/29/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/16/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/08/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-8 Labeling

Label is not available on this site.

08/10/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/10/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/10/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/02/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1991 SUPPL-3 Labeling

Label is not available on this site.

09/04/1991 SUPPL-1 Labeling

Label is not available on this site.

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