Drugs@FDA: FDA-Approved Drugs
Company: SALIX PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEPCID | FAMOTIDINE | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/02/1987 | 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 |
---|---|---|---|---|---|
07/23/2024 | SUPPL-32 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019527Origs032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019527Origs032ltr.pdf | |
08/15/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019527s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019527Orig1s031ltr.pdf | |
11/05/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019527s028ltr.pdf | |
11/24/2004 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19527s027ltr.pdf | |
03/14/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
06/06/2002 | SUPPL-24 | 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-23 | Labeling |
Label is not available on this site. |
||
11/27/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
10/13/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1999 | SUPPL-20 | 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-19 | Labeling |
Label is not available on this site. |
||
10/28/1997 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/22/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
08/12/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
02/01/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/29/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/29/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/29/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
11/30/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/22/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
12/10/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/30/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/30/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/28/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/29/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/23/1988 | 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 |
---|---|---|---|---|---|
07/23/2024 | SUPPL-32 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019527Origs032lbl.pdf |
08/15/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019527s031lbl.pdf | |
11/05/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf | |
11/24/2004 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf | |
06/06/2002 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf |