Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211309
Company: SAPTALIS PHARMS
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 |