Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020013
Company: PHARMACIA
Company: PHARMACIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MAXAQUIN | LOMEFLOXACIN HYDROCHLORIDE | EQ 400MG 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 |
---|---|---|---|---|---|---|---|
02/21/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
03/16/2005 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20013s015ltr.pdf | |
03/06/2004 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20013slr014ltr.pdf | |
05/06/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/06/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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05/06/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/11/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/20/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/24/2001 | SUPPL-8 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf | |
10/09/1996 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
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09/27/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/20/1993 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/21/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/16/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf | |
03/06/2004 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf | |
10/24/2001 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf |