Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040001
Company: ANI PHARMS

Products on ANDA 040001

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	AB	No	No
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1993	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
12/13/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/26/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
12/07/2000	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
12/07/2000	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
12/07/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
03/23/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/13/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/07/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040001

METHAZOLAMIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	217408	AJANTA PHARMA LTD
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	040062	ANDA REPOSITORY
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	040001	ANI PHARMS
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	207438	BAUSCH AND LOMB INC
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	040036	CHARTWELL RX
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	215615	TAGI

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	217408	AJANTA PHARMA LTD
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	040062	ANDA REPOSITORY
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	040001	ANI PHARMS
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	207438	BAUSCH AND LOMB INC
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	040036	CHARTWELL RX
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	215615	TAGI