Application 021887
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALLI | ORLISTAT | CAPSULE;ORAL | 60MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0135-0461 | ALLI | orlistat | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0461 | ALLI | orlistat | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0461 | ALLI | orlistat | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85596 | SUPPL | 2026-03-31 |
| 85595 | SUPPL | 2026-03-31 |
| 48401 | SUPPL | 2017-05-17 |
| 48393 | SUPPL | 2017-05-17 |
| 28788 | SUPPL | 2016-05-27 |
| 37831 | SUPPL | 2016-05-26 |
| 16525 | SUPPL | 2014-08-05 |
| 28787 | SUPPL | 2014-06-18 |
| 6391 | SUPPL | 2011-03-14 |
| 6390 | SUPPL | 2011-02-14 |
| 28786 | SUPPL | 2010-09-27 |
| 42339 | ORIG | 2007-04-10 |
| 6389 | ORIG | 2007-02-12 |
| 16524 | ORIG | 2007-02-08 |