Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090623
Company: AUROBINDO PHARMA LTD
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 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
07/28/2010 ORIG-1 Approval

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 076124 ACTAVIS MID ATLANTIC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 078312 AMNEAL PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 090054 ANDA REPOSITORY
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 090623 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 078684 BRECKENRIDGE PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 091078 HI TECH PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 078890 LANNETT CO INC
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 091091 NOSTRUM LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 077405 PHARM ASSOC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 077476 TARO
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;ORAL Prescription No AA 090102 TORRENT

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