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ACARBOSE از شرکت HIKMA PHARMS

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ACARBOSE از شرکت HIKMA PHARMS

Abbreviated New Drug Application (ANDA): 078470

Company: HIKMA PHARMS

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
05/07/2008 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078470s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/25/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/24/2008 SUPPL-1 Labeling

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 078470 HIKMA PHARMS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
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

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 078470 HIKMA PHARMS
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
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

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 078470 HIKMA PHARMS
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
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
حتما بخوانید : ACARBOSE از شرکت STRIDES PHARMA
بخوانید  ACARBOSE از شرکت EMCURE PHARMS LTD
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