Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075457
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 04/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75457ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75457ta.pdf |