Application 065427
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYCYCLINE | DOXYCYCLINE | TABLET;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065427-001 | DOXYCYCLINE | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 |
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 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065427-001 | DOXYCYCLINE | EQ 150MG BASE | TABLET / ORAL | 2007-06-07 | cb3db0bc1861… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| doxycycline | DOXYCYCLINE | Preferred Pharmaceuticals Inc. | bcc95094-80ed-4023-b2a6-955a4810bfbe | 2026-07-30 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Wellhouse Pharma, LLC | 57f97f68-11fb-4900-9efb-ca3b00818d8e | 2026-07-24 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 04de98f3-33a2-48ba-85b5-9fac867524b7 | 2026-07-15 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Golden State Medical Supply, Inc. | e9997efa-9ad8-3870-e053-2a95a90a1ac3 | 2026-07-06 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | REMEDYREPACK INC. | fa2d9328-b688-47af-8c4d-dc328cf35392 | 2026-06-24 | Warnings, Adverse reactions | DOXYCYCLINE DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE HYCLATE | Acella Pharmaceuticals, LLC | 3fb9f5ad-90a2-4858-bc34-f800d8b2fa90 | 2026-06-19 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | c96d3986-9d92-4ec4-a319-a50aeb2f4fe7 | 2026-06-12 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline | DOXYCYCLINE | Strides Pharma Science Limited | 9e710113-f25e-46fb-8327-7a8e649613a2 | 2026-06-10 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 55873d3e-09c4-4726-acfe-5da581589575 | 2026-05-22 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | REMEDYREPACK INC. | d3c0b756-30ba-4ef9-a178-fd785d720373 | 2026-05-20 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | REMEDYREPACK INC. | f0fbf63a-e75c-40cf-b2e9-429deaac899d | 2026-05-06 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | ST. MARY'S MEDICAL PARK PHARMACY | 00b2aa98-dea2-90c3-e063-6294a90a35d6 | 2026-05-01 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | American Health Packaging | e49f8ff9-af7a-47eb-929b-238cff381c03 | 2026-04-29 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Preferred Pharmaceuticals Inc. | 7f882f1a-fe75-4592-9df5-f0e4bf1d232e | 2026-04-08 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Meitheal Pharmaceuticals Inc. | 7772e702-20b3-473a-8bd5-9c7c92e753c6 | 2026-04-07 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | PD-Rx Pharmaceuticals, Inc. | 7028b7f9-21cd-4c8e-97aa-a3e7d849939b | 2026-03-27 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | PD-Rx Pharmaceuticals, Inc. | dedebcb4-3c3f-4487-a488-36af12640c92 | 2026-03-25 | Warnings, Adverse reactions | doxycycline DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | DIRECT RX | 31512ece-cb16-2a9a-e054-00144ff88e88 | 2026-03-05 | Warnings, Adverse reactions | DOXYCYCLINE DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Proficient Rx LP | d9388b32-dcb8-4dff-8a35-8fccb31bd1f8 | 2026-03-01 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | American Health Packaging | 3fbf4bb8-036e-41d3-9628-476fc05ddd31 | 2026-02-23 | Warnings, Adverse reactions | Doxycycline DOXYCYCLINE |