Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074610
Company: ANI PHARMS INC
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 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
09/26/1996 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
08/30/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

01/24/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/14/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-1 Manufacturing (CMC)

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English