Application 020381
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 375MG | No | No |
| 002 | NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 500MG | Yes | No |
| 003 | NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 750MG | Yes | Yes |
| 004 | NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 1GM | Yes | Yes |
| 005 | NIASPAN TITRATION STARTER PACK | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 375MG;500MG;750MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-3265 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3265 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3265 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3265 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3265 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3274 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3274 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3274 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3274 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3274 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3275 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3275 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3275 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3275 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 0074-3275 | Niaspan | Niacin | AbbVie Inc. | NDA | Current |
| 21695-852 | Niaspan | Niacin | Rebel Distributors Corp | NDA | Current |
| 21695-865 | Niaspan | Niacin | Rebel Distributors Corp | NDA | Current |
| 50090-1536 | Niaspan | Niacin | A-S Medication Solutions | NDA | Current |
| 68151-4068 | Niaspan | Niacin | Carilion Materials Management | NDA | Current |
| 68151-4069 | Niaspan | Niacin | Carilion Materials Management | NDA | Current |
| 68258-6032 | Niaspan | Niacin | Dispensing Solutions, Inc. | NDA | Current |
| 68258-6037 | Niaspan | Niacin | Dispensing Solutions, Inc. | NDA | Current |
| 68382-201 | Niacin | Niacin | Zydus Pharmaceuticals USA Inc | NDA | Current |
| 68382-203 | Niacin | Niacin | Zydus Pharmaceuticals USA Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70980 | SUPPL | 2022-05-04 |
| 70928 | SUPPL | 2022-05-03 |
| 64564 | SUPPL | 2020-09-11 |
| 64540 | SUPPL | 2020-09-10 |
| 2437 | SUPPL | 2015-04-28 |
| 34583 | SUPPL | 2015-04-27 |
| 34582 | SUPPL | 2013-02-26 |
| 2436 | SUPPL | 2013-02-25 |
| 24877 | SUPPL | 2010-11-12 |
| 12506 | SUPPL | 2010-11-12 |
| 24876 | SUPPL | 2010-03-03 |
| 12505 | SUPPL | 2010-03-03 |
| 24875 | SUPPL | 2009-11-12 |
| 2435 | SUPPL | 2009-11-12 |
| 34581 | SUPPL | 2009-09-21 |
| 12504 | SUPPL | 2009-09-21 |
| 2434 | SUPPL | 2009-04-01 |
| 2432 | SUPPL | 2008-05-30 |
| 2433 | SUPPL | 2008-01-09 |
| 34580 | SUPPL | 2007-12-27 |
| 2431 | SUPPL | 2007-04-09 |
| 34579 | SUPPL | 2006-04-12 |
| 24874 | SUPPL | 2006-04-12 |
| 34578 | SUPPL | 2005-09-15 |
| 2430 | SUPPL | 2005-09-15 |
| 12503 | SUPPL | 2005-06-10 |
| 2429 | SUPPL | 2005-06-10 |
| 24873 | SUPPL | 2004-06-10 |
| 34577 | SUPPL | 2003-03-05 |
| 24872 | SUPPL | 1999-10-28 |
| 2428 | SUPPL | 1999-09-13 |