Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209674
Company: NOVAST LABS
Company: NOVAST LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
11/02/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213651 | AJANTA PHARMA LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 090692 | LUPIN LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 200690 | MYLAN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203832 | NOSTRUM LABS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209674 | NOVAST LABS |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209993 | QINGDAO BAHEAL PHARM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 214629 | SCIEGEN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213247 | TWI PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FORTAMET | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 021574 | ANDRX LABS LLC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213651 | AJANTA PHARMA LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 090692 | LUPIN LTD |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 200690 | MYLAN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203832 | NOSTRUM LABS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209674 | NOVAST LABS |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209993 | QINGDAO BAHEAL PHARM |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 214629 | SCIEGEN PHARMS INC |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 213247 | TWI PHARMS |