Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074509
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/17/1995 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
06/05/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/26/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/07/2009 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/29/2009 SUPPL-9 Labeling

Label is not available on this site.

02/19/2009 SUPPL-8 Labeling

Label is not available on this site.

09/03/2008 SUPPL-7 Labeling

Label is not available on this site.

09/14/2007 SUPPL-6 Labeling

Label is not available on this site.

05/01/2006 SUPPL-4 Labeling

Label is not available on this site.

09/18/2002 SUPPL-3 Labeling

Label is not available on this site.

07/20/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/20/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMANTADINE HYDROCHLORIDE

SYRUP;ORAL; 50MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 075819 CMP PHARMA INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074170 HI TECH PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074028 MIKART
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074509 PHARM ASSOC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 075060 WOCKHARDT

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