Application 050805
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORACEA | DOXYCYCLINE | CAPSULE;ORAL | 40MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-3822 | ORACEA | DOXYCYCLINE | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3822 | ORACEA | DOXYCYCLINE | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3822 | ORACEA | DOXYCYCLINE | Galderma Laboratories, L.P. | NDA | Current |
| 0299-3822 | ORACEA | DOXYCYCLINE | Galderma Laboratories, L.P. | NDA | Current |
| 66993-815 | DOXYCYCLINE | DOXYCYCLINE | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-815 | DOXYCYCLINE | DOXYCYCLINE | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-815 | DOXYCYCLINE | DOXYCYCLINE | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 69007-822 | DOXYCYCLINE | DOXYCYCLINE | Owen Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82356 | SUPPL | 2025-05-30 |
| 81873 | SUPPL | 2025-04-08 |
| 69702 | SUPPL | 2021-12-21 |
| 69617 | SUPPL | 2021-12-17 |
| 39372 | SUPPL | 2013-07-30 |
| 8327 | SUPPL | 2013-07-29 |
| 39371 | SUPPL | 2012-11-08 |
| 8326 | SUPPL | 2012-11-08 |
| 39370 | SUPPL | 2010-05-17 |
| 30593 | SUPPL | 2010-05-17 |
| 42749 | ORIG | 2008-02-22 |
| 39369 | ORIG | 2006-05-30 |
| 8325 | ORIG | 2006-05-30 |