Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019462
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEPCID | FAMOTIDINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PEPCID | FAMOTIDINE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/15/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019462Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/11/2018 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019462Orig1s040ltr.pdf | |
| 06/21/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019462Orig1s039ltr.pdf | |
| 02/03/2014 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf | |
| 06/02/2011 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019462s037ltr.pdf | |
| 03/23/2010 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf | |
| 11/05/2007 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf | |
| 04/29/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/2001 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf |
| 06/06/2002 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf | |
| 04/25/2001 | SUPPL-29 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf | |
| 11/27/2000 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-27 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf |
| 10/08/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/08/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/12/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/09/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/06/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1996 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/22/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/10/1991 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/16/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/18/1988 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/17/1988 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/01/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/12/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/11/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s040lbl.pdf | |
| 06/21/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf | |
| 02/03/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf | |
| 06/02/2011 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf | |
| 03/23/2010 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf | |
| 11/05/2007 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf | |
| 06/06/2002 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf | |
| 04/25/2001 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf | |
| 10/15/1986 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf |