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DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PERIOSTAT | DOXYCYCLINE HYCLATE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 |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2026-08 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 84e616aacf4f… | |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2026-07 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | caaa826d4ba7… | |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2026-02 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 011fe1cb6892… | |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2025-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 31067a03dcf5… | |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 | A-S Medication Solutions | bea36ec9-f7fd-4295-bfbd-0228cffcddd7 | 2026-02-08 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Sportpharm LLC | 45c4b584-b7e2-4e91-a93d-aff14feb606f | 2026-02-06 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Sportpharm LLC | 50617adc-8528-414d-bb6c-78887d404983 | 2026-02-05 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 6e06e73c-b777-4a2d-988f-b009f2fc34d1 | 2026-01-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0 | 2026-01-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 6f530f28-8c10-41dc-818f-1aef2306bde5 | 2026-01-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | RedPharm Drug, Inc. | bdacaaa7-b46e-ee0c-e053-2a95a90aea3c | 2026-01-23 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Zhejiang Yongtai Pharmaceutical Co., Ltd | ccf9708a-ed3b-4786-b3a6-e96125b2f9d5 | 2026-01-22 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Northwind Health Company, LLC | f7f6dc0d-cf8f-50b5-e053-6294a90a9e59 | 2026-01-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Northwind Health Company, LLC | f309ccbb-b68a-3190-e053-2995a90a0ad4 | 2026-01-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Health Department, Oklahoma State | f39365f9-eb64-00cb-e053-2995a90a8d80 | 2025-12-31 | Warnings | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Macleods Pharmaceuticals Limited | c36798a1-b865-4e94-9905-5af024a9e250 | 2025-12-29 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Major Pharmaceuticals | c4aae81f-0219-450f-aa60-953964f74172 | 2025-12-23 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | QPharma, Inc. | fbd0a22f-b365-c0a2-e053-6394a90a1e07 | 2025-12-19 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Golden State Medical Supply, Inc. | 98bf51e7-01f8-e3f7-e053-2995a90a42f0 | 2025-12-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Macleods Pharmaceuticals Limited | 2696f799-7902-4239-807a-9ae85a5d0f1d | 2025-12-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | AvPAK | 53ff9f7e-0db0-c841-d334-4cf31f658828 | 2025-12-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE DELAYED RELEASE | DOXYCYCLINE HYCLATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f5ee43b2-d6ca-4819-a3d7-07f8421015d7 | 2025-12-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Redpharm Drug | 44f2fdde-cf84-6f42-e063-6394a90af94e | 2025-12-11 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | ca63aa91-519d-429f-adfc-a4ec45367294 | 2025-12-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.