Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077806
Company: HIKMA

Products on ANDA 077806

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 077806

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				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/08/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/08/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/30/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/30/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/13/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077806

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 INC
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077806	HIKMA
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