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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077405
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML 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
09/21/2007 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
10/27/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/31/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/28/2009 SUPPL-1 Labeling

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

SYRUP;ORAL; EQ 15MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 091288 LANNETT CO INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 077405 PHARM ASSOC
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