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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077612
Company: PRASCO

Products on ANDA 077612

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	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077612

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2006	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
02/21/2025	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/24/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/12/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/25/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/13/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077612s005lbl.pdf
11/01/2007	SUPPL-2	Labeling		Label is not available on this site.
05/31/2007	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 077612

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077612s005lbl.pdf

Therapeutic Equivalents for ANDA 077612

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SUSPENSION;ORAL; 200MG/5ML;40MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	091348	AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	077785	CHARTWELL MOLECULAR
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	214330	NOVITIUM PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	077612	PRASCO
SULFATRIM PEDIATRIC	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	018615	PHARM ASSOC

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