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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211925
Company: MICRO LABS

Products on ANDA 211925

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET;ORAL	Prescription	AB	No	No
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211925

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211925

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL; EQ 12.5MG BASE;5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET;ORAL	Prescription	No	AB	211925	MICRO LABS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET;ORAL	Prescription	No	AB	071297	MYLAN PHARMS INC

TABLET;ORAL; EQ 25MG BASE;10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET;ORAL	Prescription	No	AB	211925	MICRO LABS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET;ORAL	Prescription	No	AB	071297	MYLAN PHARMS INC

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