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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215453
Company: COREPHARMA

Products on ANDA 215453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215453

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

CAPSULE;ORAL; 5MG;2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	216969	ALEMBIC
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	214065	ALKEM LABS LTD
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	215555	AMNEAL
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	216419	AUROBINDO PHARMA LTD
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	213530	CHARTWELL RX
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	215453	COREPHARMA
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	214698	DR REDDYS
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	215835	MICRO LABS
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	210579	MISEMER
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	211421	NUVO PHARMS INC
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	No	AB	212344	WINDER LABS LLC
LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	Yes	AB	012750	BAUSCH

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