Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200484
Company: SUN PHARM
Company: SUN PHARM
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 | 1GM | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
04/23/2014 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200484Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/02/2023 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/02/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/09/2015 | SUPPL-1 | Labeling-Package Insert |
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; 1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203578 | AMNEAL PHARMS |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209236 | AUROBINDO PHARMA LTD |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076250 | BARR |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090446 | CHARTWELL RX |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213090 | HIBROW HLTHCARE |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203899 | LANNETT CO INC |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204934 | MACLEODS PHARMS LTD |
NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200484 | SUN PHARM |