Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075060
Company: WOCKHARDT
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
12/24/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75060ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/14/2007 SUPPL-3 Labeling

Label is not available on this site.

01/12/2007 SUPPL-2 Labeling

Label is not available on this site.

08/15/2001 SUPPL-1 Manufacturing (CMC)-Control

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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