Drugs@FDA: FDA-Approved Drugs
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.cfm | |
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 |