Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211421
Company: NUVO PHARMS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211421Orig1s000ltr.pdf

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 214065 ALKEM LABS LTD
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 213530 ECI PHARMS LLC
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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