Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075704
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/13/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |