Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074028
Company: MIKART
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
06/28/1993 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
01/18/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/22/2006 SUPPL-12 Labeling

Label is not available on this site.

08/13/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/04/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/04/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/12/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-4 Labeling

Label is not available on this site.

01/25/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/27/1994 SUPPL-1 Labeling

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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