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 | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/2020 | ORIG-1 | Approval | STANDARD |
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 | 211309 | SAPTALIS PHARMS |
| RIOMET | METFORMIN HYDROCHLORIDE | 500MG/5ML | SOLUTION;ORAL | Prescription | Yes | AB | 021591 | RANBAXY |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English