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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019593
Company: PAI HOLDINGS PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC IN PLASTIC CONTAINER RANITIDINE HYDROCHLORIDE EQ 50MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
ZANTAC IN PLASTIC CONTAINER RANITIDINE HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
12/17/1986 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-42 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-39 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-38 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf
12/13/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
01/15/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/2002 SUPPL-33 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-32 Labeling

Label is not available on this site.
10/29/1999 SUPPL-31 Labeling

Label is not available on this site.
10/22/1999 SUPPL-30 Labeling

Label is not available on this site.
10/22/1999 SUPPL-29 Labeling

Label is not available on this site.
10/29/1999 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacivinjection_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacinjection.html
11/03/1994 SUPPL-26 Labeling

Label is not available on this site.
08/10/1994 SUPPL-25 Labeling

Label is not available on this site.
08/12/1992 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
04/05/1993 SUPPL-21 Labeling

Label is not available on this site.
07/22/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/18/1992 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/05/1991 SUPPL-18 Labeling

Label is not available on this site.
12/20/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
11/21/1990 SUPPL-16 Labeling

Label is not available on this site.
01/17/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
12/12/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
07/16/1990 SUPPL-13 Labeling

Label is not available on this site.
11/25/1991 SUPPL-12 Labeling

Label is not available on this site.
08/13/1990 SUPPL-11 Labeling

Label is not available on this site.
05/18/1989 SUPPL-10 Labeling

Label is not available on this site.
08/08/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
05/20/1988 SUPPL-7 Labeling

Label is not available on this site.
05/20/1988 SUPPL-6 Labeling

Label is not available on this site.
03/17/1989 SUPPL-5 Labeling

Label is not available on this site.
01/04/1988 SUPPL-4 Labeling

Label is not available on this site.
05/18/1987 SUPPL-2 Manufacturing (CMC)-Packaging

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-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf
02/17/2009 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf
10/29/1999 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf
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