Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074664
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;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
10/28/1997 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074664.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/13/2019 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

CIMETIDINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 300MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;ORAL Prescription No AA 074610 ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;ORAL Prescription No AA 074664 HI TECH PHARMA
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;ORAL Prescription No AA 074553 PHARM ASSOC
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;ORAL Prescription No AA 074757 WOCKHARDT BIO AG

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