Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075650
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| 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 |
|---|---|---|---|---|---|---|---|
| 09/14/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75650d2.apf.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75650ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/75650ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |