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CHLORPROMAZINE HYDROCHLORIDE از شرکت GLENMARK PHARMS LTD

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CHLORPROMAZINE HYDROCHLORIDE از شرکت GLENMARK PHARMS LTD

Abbreviated New Drug Application (ANDA): 212144

Company: GLENMARK PHARMS LTD

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
03/23/2021 ORIG-1 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212144Orig1s000ltr.pdf

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 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 083386 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 213368 ZYDUS

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 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 084112 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 213368 ZYDUS

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 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 084113 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 213368 ZYDUS

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 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 084114 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 213368 ZYDUS

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 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 084115 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 213368 ZYDUS
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بخوانید  CHLORPROMAZINE HYDROCHLORIDE از شرکت WEST WARD
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