Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204178
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/11/2015 | ORIG-1 | Approval |
Label is not available on this site. |
NIACIN
TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204178 | AMNEAL PHARMS |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209236 | AUROBINDO PHARMA LTD |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076378 | BARR |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090892 | CHARTWELL RX |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213090 | EYWA |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201273 | SUN PHARM |