Application 050533
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIBRA-TABS | DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050533-001 | VIBRA-TABS | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050533-001 | VIBRA-TABS | EQ 100MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050533-001 | VIBRA-TABS | EQ 100MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 8c525e4e-6e1b-4579-e053-2a95a90a43da | 2025-11-18 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | American Health Packaging | e98d11b0-535f-4e57-9639-6358835c04bc | 2025-11-13 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Ajanta Pharma USA Inc. | 9f00b2c9-e628-4265-8530-3258dd3cdcd5 | 2025-11-04 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 2025-10-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 6624a43a-28ff-4d55-b5dd-1e805bfa8778 | 2025-10-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Hikma Pharmaceuticals USA Inc. | 4ec4c8ca-ce83-4948-8626-21eb82ae5c19 | 2025-10-28 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| TARGADOX | DOXYCYCLINE HYCLATE | Journey Medical Corporation | 83243f78-b984-46a4-a88a-c6a15c217b90 | 2025-10-21 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | Cardinal Health 107, LLC | 53deb73a-c828-46e8-994e-d84e3bf8dc98 | 2025-10-02 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Ajanta Pharma USA Inc. | f18daceb-33a3-4931-9be7-ecd6356cc119 | 2025-10-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Chartwell Governmental & Specialty RX, LLC | b8486639-7eb9-4610-9cd4-0e922045d592 | 2025-09-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Chartwell RX LLC | 3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35 | 2025-09-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Viona Pharmaceuticals Inc | 51d245a3-ef51-474a-bc91-377d5f42dde3 | 2025-08-25 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | 131af052-0c4f-4a61-ae9a-e6165ae09076 | 2025-08-19 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Hikma Pharmaceuticals USA Inc. | 9b52e0a7-f024-4d8a-a59e-374946e60b44 | 2025-08-15 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Viona Pharmaceuticals Inc | 763997f0-b35c-43cb-a792-3e0bae589536 | 2025-08-12 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | JG Pharma Inc. | 10b8bf71-4311-41e8-a891-bab8bc86863f | 2025-08-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Larken Laboratories, Inc. | 49f82130-6f8a-412c-b625-e75906e74675 | 2025-07-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | b612d2f5-b703-47f0-b5eb-b66a7aeed577 | 2025-06-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Actavis Pharma, Inc. | a569ba80-ffea-40b2-9fbe-a42810b1fccb | 2025-06-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 294c6fc3-e7ca-46ea-b062-a27dd7b0bc97 | 2025-06-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83085 | SUPPL | 2025-08-12 |
| 83081 | SUPPL | 2025-08-11 |
| 81847 | SUPPL | 2025-04-08 |
| 81791 | SUPPL | 2025-04-02 |
| 61439 | SUPPL | 2019-12-26 |
| 61414 | SUPPL | 2019-12-23 |
| 56671 | SUPPL | 2018-12-07 |
| 56628 | SUPPL | 2018-12-04 |
| 49114 | SUPPL | 2017-07-28 |
| 49095 | SUPPL | 2017-07-27 |
| 46592 | SUPPL | 2016-12-29 |
| 46500 | SUPPL | 2016-12-21 |
| 38965 | SUPPL | 2016-04-07 |
| 30055 | SUPPL | 2016-04-05 |
| 38964 | SUPPL | 2014-10-02 |
| 30054 | SUPPL | 2014-09-16 |
| 17855 | SUPPL | 2013-09-09 |
| 7792 | SUPPL | 2013-09-09 |
| 17854 | SUPPL | 2013-05-01 |
| 30053 | SUPPL | 2013-04-30 |
| 38963 | SUPPL | 2011-05-16 |
| 38962 | SUPPL | 2008-02-14 |
| 30052 | SUPPL | 2008-02-13 |
| 7791 | SUPPL | 2004-03-16 |
| 7790 | SUPPL | 2002-06-18 |