U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012750
Company: BAUSCH
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
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
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-Package Insert, Labeling-Medication Guide 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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
Back to Top