Details for New Drug Application (NDA): 203578
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NDA 203578 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in thirty NDAs. It is available from eight suppliers. Additional details are available on the NIACIN profile page.
The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 203578
| Tradename: | NIACIN |
| Applicant: | Amneal Pharms |
| Ingredient: | niacin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 203578 | ANDA | AvPAK | 50268-584 | 50268-584-13 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11) |
| NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 203578 | ANDA | Amneal Pharmaceuticals LLC | 65162-321 | 65162-321-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No | ||||
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