Application 050007
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 100MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div P | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0950 | Vibramycin Hyclate | doxycycline hyclate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-3690 | Doxycycline | doxycycline hyclate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83083 | SUPPL | 2025-08-12 |
| 83079 | SUPPL | 2025-08-11 |
| 81845 | SUPPL | 2025-04-08 |
| 81789 | SUPPL | 2025-04-02 |
| 61437 | SUPPL | 2019-12-26 |
| 61412 | SUPPL | 2019-12-23 |
| 56669 | SUPPL | 2018-12-07 |
| 56625 | SUPPL | 2018-12-04 |
| 49111 | SUPPL | 2017-07-28 |
| 49092 | SUPPL | 2017-07-27 |
| 46589 | SUPPL | 2016-12-29 |
| 46503 | SUPPL | 2016-12-21 |
| 38908 | SUPPL | 2016-04-07 |
| 29975 | SUPPL | 2016-04-05 |
| 38907 | SUPPL | 2015-05-07 |
| 38906 | SUPPL | 2014-10-02 |
| 29974 | SUPPL | 2014-09-16 |
| 17794 | SUPPL | 2013-09-09 |
| 7687 | SUPPL | 2013-09-09 |
| 17793 | SUPPL | 2013-05-01 |
| 7686 | SUPPL | 2013-05-01 |
| 17792 | SUPPL | 2011-05-16 |
| 17791 | SUPPL | 2008-02-14 |
| 7685 | SUPPL | 2008-02-13 |
| 29973 | SUPPL | 2004-03-16 |
| 29972 | SUPPL | 2002-06-18 |