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DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PERIOSTAT | DOXYCYCLINE HYCLATE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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2026-02 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 011fe1cb6892… | |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2025-12 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 31067a03dcf5… | |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2025-08 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | 6a471c1ec25d… | |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2025-03 | N050783-001 | PERIOSTAT | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-02-02 | fd3edfee7708… | |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… | |
| 2022-09-29 23:25 UTC | 2022-09 | 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 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | 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 | cb3db0bc1861… |
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 | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 2c29f716-bdb0-437d-92a4-d856b87db976 | 2026-08-06 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 2305ab4a-7d08-41f6-9c39-c9b6835be389 | 2026-08-05 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | c8194d6e-c407-465e-a342-4d2d9756dfc4 | 2026-08-04 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | db53637e-16ac-41b0-b9d5-553471405d64 | 2026-08-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c | 2026-07-29 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 3af9348c-a98b-4059-a5ef-4229e2b33af0 | 2026-07-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 0994d23a-f9e4-4c33-ba44-a1f4ae4a312c | 2026-07-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 1401d590-0967-4c6b-b52b-a83e9f6df097 | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | b988f851-cc06-4570-9706-cf65d370bd8e | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 35aa295e-ff1b-453b-8eeb-65bbeda3baa5 | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | HAWAII REPACK, INC | 88c429a1-351d-432e-b69b-d7a0afca482a | 2026-07-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycyclate Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 2026-07-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 6e3d0691-c071-441c-9b00-22a380305066 | 2026-07-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Chartwell RX, LLC | fad03768-f1d2-459f-965e-0ec29f189f1f | 2026-06-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Strides Pharma Science Limited | 2deeee4f-b342-a178-e063-6394a90af897 | 2026-06-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Strides Pharma Science Limited | b8b76aaa-575b-497f-b854-c42bc992c784 | 2026-06-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | St. Mary's Medical Park Pharmacy | 02f87c60-8425-1a1e-e063-6294a90a0c94 | 2026-06-25 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Slate Run Pharmaceuticals, LLC | f31e69fc-e513-40e4-91b5-22ccf1ed9437 | 2026-06-23 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | Acella Pharmaceuticals, LLC | 3fb9f5ad-90a2-4858-bc34-f800d8b2fa90 | 2026-06-19 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Unit Dose Solutions, Inc. | 548d4218-2feb-8716-e063-6394a90afbe3 | 2026-06-18 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |