Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077807
Company: NOVITIUM PHARMA

Products on ANDA 077807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2007	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077807_original_approval_pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/23/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/23/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077807

BALSALAZIDE DISODIUM

CAPSULE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077883	APOTEX
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	219422	CARNEGIE
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077806	HIKMA
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077807	NOVITIUM PHARMA
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	217592	ZYDUS LIFESCIENCES
COLAZAL	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	Yes	AB	020610	VALEANT PHARMS INTL