Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207438
Company: BAUSCH AND LOMB INC

Products on ANDA 207438

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 207438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207438

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	040001	ANI PHARMS
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	207438	BAUSCH AND LOMB INC
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	040062	MIKART
METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET;ORAL	Prescription	No	AB	040036	SANDOZ
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	040001	ANI PHARMS
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	207438	BAUSCH AND LOMB INC
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	040062	MIKART
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	040036	SANDOZ
METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	215615	TAGI