Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020087
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLOXIN | OFLOXACIN | 20MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLOXIN | OFLOXACIN | 40MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLOXIN IN DEXTROSE 5% | OFLOXACIN | 400MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | OFLOXACIN | 4MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | OFLOXACIN | 400MG/100ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/1999 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/08/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/25/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1999 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/12/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1996 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
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| 08/11/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 09/11/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/22/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/27/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1993 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/10/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |