An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216393
Company: NOVITIUM PHARMA

Products on ANDA 216393

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 216393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216393

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

Top