Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076378
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
04/26/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076378ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/07/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
12/20/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/19/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
NIACIN
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203578 | AMNEAL PHARMS |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209236 | AUROBINDO PHARMA LTD |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076378 | BARR |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090860 | CHARTWELL RX |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213090 | HIBROW HLTHCARE |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203899 | LANNETT CO INC |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204934 | MACLEODS PHARMS LTD |
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200484 | SUN PHARM |
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 | HIBROW HLTHCARE |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201273 | SUN PHARM |