Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208336
Company: SUNSHINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription AB No No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET;ORAL Prescription AB No No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM 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
08/30/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208336Orig1s000ltr.pdf

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 2.5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription Yes AB 201281 BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET;ORAL Prescription No AB 208336 SUNSHINE

TABLET;ORAL; 2.5MG;850MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET;ORAL Prescription Yes AB 201281 BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET;ORAL Prescription No AB 208336 SUNSHINE

TABLET;ORAL; 2.5MG;1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET;ORAL Prescription Yes AB 201281 BOEHRINGER INGELHEIM
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET;ORAL Prescription No AB 208336 SUNSHINE

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