Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076136
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 12/26/2001 | ORIG-1 | Tentative Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76136.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76136ltr.pdf |