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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074650
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;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
12/29/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074650Orig1s000ChemR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2025 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
06/24/2024 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
07/06/2022 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/24/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
12/15/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.pdf
09/15/2009 SUPPL-8 Labeling

Label is not available on this site.
04/21/2000 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
01/24/2000 SUPPL-2 Labeling

Label is not available on this site.
01/24/2000 SUPPL-1 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
12/15/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.pdf
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