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 | Larken Laboratories, Inc. | 49f82130-6f8a-412c-b625-e75906e74675 | 2025-07-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2bcde264-5f6f-47f6-ae2e-1b7010deacf7 | 2025-07-18 | Warnings, Adverse reactions | Doxycycline |
| 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 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 6772807d-a39e-47ce-9584-a08e7f8940d2 | 2025-06-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE | DOXYCYCLINE | Alembic Pharmaceuticals Inc. | a50e953d-447b-4b66-b567-04586174d3f9 | 2025-06-16 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Macleods Pharmaceuticals Limited | 10aca485-850b-4c82-bb7e-5fac2d7a62ce | 2025-06-07 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Dr.Reddys Laboratories Inc | 7a28cce1-4805-b3d1-4484-e7a49c597660 | 2025-06-06 | Warnings, Adverse reactions | Doxycycline |
| DOXYCYCLINE | DOXYCYCLINE | Lupin Pharmaceuticals, Inc. | 81c5a7fc-3fe0-40b2-bae0-c79eb0b27697 | 2025-06-04 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | b46208a2-5072-4df5-b2af-379f865545d2 | 2025-06-02 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Asclemed USA, Inc. | bed39bae-64c2-44b4-9c95-682ead4e6738 | 2025-05-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Asclemed USA, Inc. | a5571acf-3284-4559-8cc0-b4856ac6d94d | 2025-05-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 2b3b3c48-eb60-400c-bdfe-50635a136c90 | 2025-05-28 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 61195fc6-3fa7-4203-b526-477b48395856 | 2025-05-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 9cbd8699-e2c2-40d4-8797-e676f2a10eb2 | 2025-05-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | 7c33c1b8-100e-4df8-be8d-de3eed7ced94 | 2025-04-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Zydus Pharmaceuticals USA Inc. | fef9580d-8850-4cbb-89eb-2b4d40ee59c9 | 2025-04-26 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Sun Pharmaceutical Industries, Inc. | 829dbd3d-5c2b-47b8-96a5-423af78c93b9 | 2025-04-24 | Warnings, Adverse reactions | Doxycycline |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Inc. | cec4368f-2852-443d-9d6f-7ba95807021b | 2025-04-16 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.