Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020695
Company: OTSUKA
Company: OTSUKA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RAXAR | GREPAFLOXACIN HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| RAXAR | GREPAFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| RAXAR | GREPAFLOXACIN HYDROCHLORIDE | EQ 600MG 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 |
|---|---|---|---|---|---|---|---|
| 11/06/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-695_Raxar_Pharma.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-3 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-695s003_Raxar.cfm |
| 08/17/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1998 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |