Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 074650

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074650

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
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.

Labels for ANDA 074650

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