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 | DOXYCYCLINE | Proficient Rx LP | c707566b-dbc7-4dac-bad1-952f2f4d6845 | 2024-02-01 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Lupin Pharmaceuticals,Inc. | b752ea66-3144-4f78-96fe-a5f4d92740a7 | 2024-01-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Lupin Pharmaceuticals,Inc. | 6512bf22-c211-4127-a8c8-2419656580f6 | 2024-01-30 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 0fdc3d87-8819-4c2c-e063-6394a90a687b | 2024-01-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Limited | e567b431-53fe-4e27-9b05-bf6eeb8abb51 | 2023-12-11 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 6aab6fee-791e-4141-b55f-685ec9d8712a | 2023-11-01 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline | DOXYCYCLINE | Proficient Rx LP | b83c4c4b-2885-43e7-b1c9-0b3bbf75528d | 2023-10-01 | Warnings, Adverse reactions | Doxycycline |
| doxycycline | DOXYCYCLINE | Asclemed USA, Inc. | f33ae6f5-bdb6-4c15-9e62-6180433bb1fb | 2023-05-04 | Warnings, Adverse reactions | doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Limited | 44ac5de1-c0c6-4d58-9a49-b2dae60ea921 | 2023-04-10 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Limited | 6e587d8d-1a82-4dfa-acea-88704d408f2f | 2023-01-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Alembic Pharmaceuticals Limited | 3dfa486c-4665-4882-93ac-9259708f899c | 2023-01-27 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Limited | 24c8472a-dd07-4f84-8bea-20a3f178d119 | 2023-01-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Alembic Pharmaceuticals Limited | ec4535a1-69f0-40a2-bcba-11afc75c721d | 2023-01-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Zydus Lifesciences Limited | 6ae11b4e-1c13-440b-a050-d76e062b0f92 | 2022-11-05 | Doxycycline | |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Proficient Rx LP | dd7672c9-b10f-4ea1-9000-ef3e3faa10db | 2022-09-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Proficient Rx LP | 86c1f165-af79-4f01-ab61-3bdbce24cd0d | 2022-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Proficient Rx LP | 2993ac3d-0ec4-4230-858e-9fd00063cf57 | 2022-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | Proficient Rx LP | 3303b423-b270-495b-9360-e43144fcf6f2 | 2021-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Proficient Rx LP | f3ba6c30-ada3-4a57-9ff8-30558202b9aa | 2019-11-01 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Sun Pharmaceutical Industries Inc. | 8224b9c5-5c4b-4dda-bc58-47b6604c2884 | 2018-08-06 | Warnings, Adverse reactions | Doxycycline |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.