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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077785
Company: CHARTWELL MOLECULAR

Products on ANDA 077785

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 077785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2007	ORIG-24	Approval				Label is not available on this site.
01/24/2007	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
09/22/2022	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/22/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/03/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077785

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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