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FDA ANDA · ANDA208473
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sponsor: PRINSTON PHARMA INC
APPLICATION
ANDA208473
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
LINAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
LINAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
Approval history
2022-04-05UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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