Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020249
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER | FAMOTIDINE | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/18/1994 | 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 |
---|---|---|---|---|---|
11/05/2007 | SUPPL-13 | 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 | |
03/14/2001 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF | |
06/06/2002 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020249_s011_PEPCID INJECTION.pdf | |
04/25/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
03/18/1999 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf |
11/12/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
08/12/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
08/19/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/03/1997 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/26/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/29/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/29/1995 | 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 |
---|---|---|---|---|---|
11/05/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf | |
06/06/2002 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf | |
03/14/2001 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF |