Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040904
Company: HERITAGE PHARMA

Products on ANDA 040904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/040904s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040904

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	207659	ACCORD HLTHCARE
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	210423	ALEMBIC
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205301	CADILA
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	040904	HERITAGE PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	090779	INDICUS PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	207401	MICRO LABS LTD INDIA
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204691	NOSTRUM LABS INC
ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203434	NOVAST LABS