Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202271
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription AB No No
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription AB No No
ACARBOSE ACARBOSE 100MG 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
02/07/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ACARBOSE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 25MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 50MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 100MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

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