Application 021470
- Type
- NDA
- Sponsor
- LEO PHARMA AS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FINACEA | AZELAIC ACID | GEL;TOPICAL | 15% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-7172 | Azelaic Acid Gel | azelaic acid | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 10922-825 | Finacea | azelaic acid | Intendis Inc. | NDA | Current |
| 10922-826 | Finacea | azelaic acid | Intendis Inc. | NDA | Current |
| 50090-3032 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50090-3032 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50090-4473 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50090-4473 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50090-4473 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50090-4473 | Finacea | azelaic acid | A-S Medication Solutions | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50222-505 | Finacea | azelaic acid | LEO Pharma Inc. | NDA | Current |
| 50419-825 | Finacea | azelaic acid | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-825 | Finacea | azelaic acid | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69212 | SUPPL | 2021-11-02 |
| 69197 | SUPPL | 2021-11-02 |
| 65425 | SUPPL | 2020-12-01 |
| 65424 | SUPPL | 2020-12-01 |
| 65363 | SUPPL | 2020-11-30 |
| 65362 | SUPPL | 2020-11-30 |
| 45022 | SUPPL | 2016-08-05 |
| 45001 | SUPPL | 2016-08-05 |
| 27877 | SUPPL | 2016-01-11 |
| 15545 | SUPPL | 2016-01-11 |
| 15544 | SUPPL | 2015-04-07 |
| 5465 | SUPPL | 2015-04-06 |
| 15543 | SUPPL | 2013-01-07 |
| 27876 | SUPPL | 2012-12-21 |
| 27875 | SUPPL | 2010-11-03 |
| 15542 | SUPPL | 2010-10-25 |
| 37014 | SUPPL | 2005-05-17 |
| 5464 | SUPPL | 2005-05-17 |
| 5463 | ORIG | 2004-06-04 |
| 21676 | ORIG | 2004-03-24 |
| 37013 | ORIG | 2002-12-24 |