Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211421
Company: NUVO PHARMS INC
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/24/2022 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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 |