Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019090
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes 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
10/19/1984 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/04/2009 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042ltr.pdf
02/17/2009 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf
07/12/2006 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf
03/14/2002 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/15/2002 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/2002 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf
05/09/2001 SUPPL-44 Labeling

Label is not available on this site.

10/29/1999 SUPPL-43 Labeling

Label is not available on this site.

04/02/1999 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/06/2001 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/22/1999 SUPPL-40 Labeling

Label is not available on this site.

10/22/1999 SUPPL-39 Labeling

Label is not available on this site.

01/14/1998 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1999 SUPPL-37 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection.cfm
11/03/1994 SUPPL-35 Labeling

Label is not available on this site.

04/05/1993 SUPPL-32 Labeling

Label is not available on this site.

07/22/1992 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1991 SUPPL-30 Labeling

Label is not available on this site.

12/20/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/19/1992 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/1990 SUPPL-27 Labeling

Label is not available on this site.

12/12/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/16/1990 SUPPL-25 Labeling

Label is not available on this site.

11/25/1991 SUPPL-24 Labeling

Label is not available on this site.

06/25/1990 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1989 SUPPL-20 Labeling

Label is not available on this site.

08/08/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/26/1990 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/13/1990 SUPPL-17 Efficacy-New Dosing Regimen

Label is not available on this site.

03/17/1989 SUPPL-16 Labeling

Label is not available on this site.

05/20/1988 SUPPL-15 Labeling

Label is not available on this site.

05/20/1988 SUPPL-14 Labeling

Label is not available on this site.

03/17/1989 SUPPL-13 Labeling

Label is not available on this site.

05/19/1988 SUPPL-12 Labeling

Label is not available on this site.

11/24/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-9 Labeling

Label is not available on this site.

03/03/1988 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/08/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/04/2009 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf
02/17/2009 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf

ZANTAC

INJECTABLE;INJECTION; EQ 25MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079076 MYLAN LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074777 WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077458 WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091534 ZYDUS PHARMS USA INC
ZANTAC RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019090 TELIGENT

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