Application 062569
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | No | Yes |
| 002 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062569-001 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | ||
| A062569-002 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 1988-03-09 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 1988-03-09 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062569-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 1988-03-09 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062569-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1988-03-09 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062569-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062569-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062569-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062569-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062569-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062569-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062569-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062569-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062569-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062569-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062569-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062569-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062569-001 | AP | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062569-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062569-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062569-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062569-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062569-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062569-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A062569-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062569-001 | AP | 1 | 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 Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 5f523294-e62b-4da5-8799-047d4bed966f | 2026-06-04 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Sun Pharmaceutical Industries, Inc. | 214a9cfe-a522-4022-81d4-e59f447401fe | 2026-06-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Coupler LLC | 52ba329a-8cb3-cf30-e063-6394a90aa0dc | 2026-05-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 55873d3e-09c4-4726-acfe-5da581589575 | 2026-05-22 | Warnings, Adverse reactions | Doxycycline |
| doxycycline | DOXYCYCLINE | REMEDYREPACK INC. | d3c0b756-30ba-4ef9-a178-fd785d720373 | 2026-05-20 | Warnings, Adverse reactions | doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 3a85933f-bd73-4ad7-968d-c90cb7c7a60c | 2026-05-13 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | ST. MARY'S MEDICAL PARK PHARMACY | 00b2aa98-dea2-90c3-e063-6294a90a35d6 | 2026-05-01 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | American Health Packaging | e49f8ff9-af7a-47eb-929b-238cff381c03 | 2026-04-29 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | 3ae4ca12-be39-46b9-bc4c-f8356776c175 | 2026-04-28 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Cardinal Health 107, LLC | a34fbbc7-09dc-42d6-a075-f4ea8f170ba7 | 2026-04-24 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 7a915c50-6fce-45e6-9554-677bb09a868d | 2026-04-13 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Preferred Pharmaceuticals Inc. | 7f882f1a-fe75-4592-9df5-f0e4bf1d232e | 2026-04-08 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Meitheal Pharmaceuticals Inc. | 7772e702-20b3-473a-8bd5-9c7c92e753c6 | 2026-04-07 | Warnings, Adverse reactions | Doxycycline |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Cranbury Pharmaceuticals, LLC | fe6985d2-37f7-4277-94a9-f7125b4b3fd7 | 2026-03-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | PD-Rx Pharmaceuticals, Inc. | 7028b7f9-21cd-4c8e-97aa-a3e7d849939b | 2026-03-27 | Warnings, Adverse reactions | doxycycline |
| doxycycline | DOXYCYCLINE | PD-Rx Pharmaceuticals, Inc. | dedebcb4-3c3f-4487-a488-36af12640c92 | 2026-03-25 | Warnings, Adverse reactions | doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Direct_Rx | 2ad2b85f-2479-c7cd-e063-6294a90acca1 | 2026-03-06 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | DIRECT RX | 9798c4de-8af7-41c4-acc2-1e9775194297 | 2026-03-05 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE | DOXYCYCLINE | DIRECT RX | 31512ece-cb16-2a9a-e054-00144ff88e88 | 2026-03-05 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 0aaa4ff7-7fba-4a40-9b49-82e4da68a48f | 2026-03-02 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.