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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211309
Company: SAPTALIS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2024 SUPPL-9 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

METFORMIN HYDROCHLORIDE

SOLUTION;ORAL; 500MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription No AB 215008 ANNORA PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription No AB 219151 BIONPHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription No AB 211309 SAPTALIS PHARMS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION;ORAL Prescription No AB 212677 VISTAPHARM LLC
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