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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018598
Company: FOSUN PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Discontinued None No No
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG 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
05/19/1982 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2021 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018598s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018598Orig1s054ltr.pdf
09/05/2019 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018598s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018598Orig1s052ltr.pdf
02/03/2011 SUPPL-51 Labeling-Package Insert Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.
02/20/2008 SUPPL-50 Labeling

Label is not available on this site.
06/23/2000 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
02/02/2000 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.
01/07/1998 SUPPL-36 Labeling

Label is not available on this site.
07/11/1996 SUPPL-35 Labeling

Label is not available on this site.
10/08/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
10/08/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
05/03/1996 SUPPL-32 Labeling

Label is not available on this site.
05/03/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
05/10/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
05/10/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
03/09/1994 SUPPL-19 Labeling

Label is not available on this site.
07/28/1992 SUPPL-18 Labeling

Label is not available on this site.
10/20/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
10/20/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
03/08/1989 SUPPL-15 Labeling

Label is not available on this site.
11/07/1988 SUPPL-14 Labeling

Label is not available on this site.
03/27/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
03/27/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
01/13/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
08/18/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
01/07/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
07/29/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/15/2021 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018598s054lbl.pdf
09/05/2019 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018598s052lbl.pdf
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