Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074929
Company: BIOPHARM
Company: BIOPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 300MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/30/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.pdf |