Drugs@FDA: FDA-Approved Drugs
Company: J AND J CONSUMER INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEPCID AC | FAMOTIDINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
PEPCID AC | FAMOTIDINE | 20MG | TABLET, CHEWABLE;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/24/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20801ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20801.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2019 | SUPPL-20 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020801Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020801Orig1s020ltr.pdf | |
03/20/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/17/2007 | SUPPL-12 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020801s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.pdf |
10/27/2004 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf |
01/31/2002 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20801s7ltr.pdf |
03/29/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20801S4ltr.pdf | |
04/26/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/06/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/20/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2019 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020801Orig1s020lbl.pdf | |
03/29/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf | |
09/24/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf |
PEPCID AC
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 20MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
PEPCID AC | FAMOTIDINE | 20MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 020801 | J AND J CONSUMER INC |