Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209755
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;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
09/10/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 083386 UPSHER SMITH LABS

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 084112 UPSHER SMITH LABS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 084113 UPSHER SMITH LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 084114 UPSHER SMITH LABS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 084115 UPSHER SMITH LABS

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