Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020752
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEPCID RPD | FAMOTIDINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| PEPCID RPD | FAMOTIDINE | 40MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/06/2002 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf | |
| 05/28/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf |