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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012750
Company: BAUSCH

Medication Guide

Products on NDA 012750

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012750

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/1966	ORIG-1	Approval	Type 4 - New Combination	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
01/13/2023	SUPPL-68	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012750s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/012750Orig1s068ltr.pdf
02/05/2021	SUPPL-67	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012750s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012750Orig1s067ltr.pdf
12/16/2016	SUPPL-66	Labeling-Medication Guide, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012750Orig1s066ltr.pdf
01/13/2017	SUPPL-65	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012750Orig1s065ltr.pdf

Labels for NDA 012750

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-68	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012750s068lbl.pdf
01/13/2023	SUPPL-68	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012750s068lbl.pdf
02/05/2021	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012750s067lbl.pdf
01/13/2017	SUPPL-65	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf

Therapeutic Equivalents for NDA 012750

LIBRAX

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	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	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
LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE;ORAL	Prescription	Yes	AB	012750	BAUSCH

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