Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091437
Company: NOVEL LABS INC

Products on ANDA 091437

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2011	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
03/12/2025	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/19/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091437

TRIMETHOPRIM

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET;ORAL	Prescription	Yes	AB	018679	DR REDDYS LABS SA
TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET;ORAL	Prescription	No	AB	091437	NOVEL LABS INC
TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET;ORAL	Prescription	No	AB	216393	NOVITIUM PHARMA
TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET;ORAL	Prescription	No	AB	070049	WATSON LABS