Application 050783
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERIOSTAT | DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050783-001 | PERIOSTAT | DOXYCYCLINE HYCLATE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 |
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2026-08 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050783-001 | PERIOSTAT | EQ 20MG BASE | TABLET / ORAL | RLD | 2001-02-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050783-001 | PERIOSTAT | EQ 20MG BASE | TABLET / ORAL | RLD | 2001-02-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-02-02 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 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.