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DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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VIBRA-TABS | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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| N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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| N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||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| N050533-001 | VIBRA-TABS | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||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 | A-S Medication Solutions | 6772807d-a39e-47ce-9584-a08e7f8940d2 | 2025-06-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Asclemed USA, Inc. | bed39bae-64c2-44b4-9c95-682ead4e6738 | 2025-05-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Asclemed USA, Inc. | a5571acf-3284-4559-8cc0-b4856ac6d94d | 2025-05-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 61195fc6-3fa7-4203-b526-477b48395856 | 2025-05-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 9cbd8699-e2c2-40d4-8797-e676f2a10eb2 | 2025-05-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | 7c33c1b8-100e-4df8-be8d-de3eed7ced94 | 2025-04-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | cec4368f-2852-443d-9d6f-7ba95807021b | 2025-04-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Chartwell RX, LLC | b3294889-e8f8-42f1-9bd0-13d87572997a | 2025-04-15 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 65cac0b6-3550-48cf-bffa-cf42443c2731 | 2025-04-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | cd2ab9b8-9619-4199-8a5d-83377b3274d1 | 2025-04-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Coupler LLC | 325d5331-d48e-1bc4-e063-6394a90a65b9 | 2025-04-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Sun Pharmaceutical Industries, Inc. | bff3f426-44fc-4dbf-96df-df44011103e8 | 2025-04-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Epic Pharma, LLC | 2b402587-8ecc-4fea-83ad-8071345b6356 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Actavis Pharma, Inc. | c2b08332-3256-4658-965a-ede3d973a388 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | e726157e-ce44-4df3-8161-7016700dd751 | 2025-03-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | EPIC PHARMA, LLC | b3cd7b44-db40-4ce5-895e-d4c85a0068ae | 2025-03-19 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 861b71f3-37e8-4596-838c-c8dad8ed5ff4 | 2025-02-04 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 942ab6dd-e355-41da-b139-72cc8b7a2667 | 2025-02-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 5b4390ed-a0ec-4ef8-864c-8a33a83653f9 | 2025-01-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Redpharm Drug, Inc. | 09d19663-a8b9-0c3f-e063-6394a90aa446 | 2025-01-23 | 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 |