Drugs@FDA: FDA-Approved Drugs
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZANTAC | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 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 |