Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020759
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TROVAN | TROVAFLOXACIN MESYLATE | EQ 100MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| TROVAN | TROVAFLOXACIN MESYLATE | EQ 200MG 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 |
|---|---|---|---|---|---|---|---|
| 12/18/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020760a.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/17/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/17/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/15/1999 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/17/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/19/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/17/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/23/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |