Application 062450
- 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 | No |
| 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 |
|---|---|---|---|---|---|---|---|
| A062450-001 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | ||
| A062450-002 | DOXYCYCLINE | DOXYCYCLINE HYCLATE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 |
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 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062450-001 | DOXYCYCLINE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062450-002 | DOXYCYCLINE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 1983-10-27 | 4b0b4de00fa7… |
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 | Bryant Ranch Prepack | 1df9e905-d2e7-4a5a-8bd6-43f4850ba900 | 2024-08-21 | Warnings, Adverse reactions | doxycycline |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Zydus Lifesciences Limited | 68b3aba5-f1e4-4cdf-b244-0302aa8595fe | 2024-08-16 | DOXYCYCLINE HYCLATE | |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | Zydus Lifesciences Limited | fc8213e3-e546-495f-ac2c-3856db79c6e1 | 2024-08-16 | DOXYCYCLINE HYCLATE | |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 214e5a5c-7f3e-478b-93d3-1713de9e7672 | 2024-08-07 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Proficient Rx LP | 716dccec-7480-44dd-91b9-249ae2c25088 | 2024-08-01 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 4b170180-21f4-4ee5-9e81-1607ab52cfca | 2024-07-18 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | a5f02688-cbba-4d9b-e053-2995a90ad1ba | 2024-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | a707c9e3-00eb-e832-e053-2a95a90a5f58 | 2024-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 5f989cc1-48ae-41bb-b297-2f8c83760b6d | 2024-07-15 | Warnings, Adverse reactions | doxycycline |
| Doxycycline | DOXYCYCLINE | Lannett Company, Inc. | 4999bbd9-44ed-4749-9730-be2337bdf490 | 2024-07-03 | Warnings, Adverse reactions | Doxycycline |
| DOXYCYCLINE | DOXYCYCLINE | Alembic Pharmaceuticals Limited | 8e78dc54-8322-435d-8879-4bfe37f1b98c | 2024-07-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | a2161675-505c-3d65-e053-2995a90aa644 | 2024-06-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 860a1566-5857-ed88-e053-2991aa0ae2a4 | 2024-06-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 88012cf8-509b-84cf-e053-2a95a90af3bc | 2024-06-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | a2df1a8c-7a22-462d-830a-04e6ac5a912f | 2024-04-28 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 1dd7a94e-bf29-4f07-9476-ac8d1f9ab565 | 2024-04-28 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 4164f6b7-5ebd-4f5f-a536-9a37b2e0562c | 2024-04-28 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | a84d7562-08bf-417f-a599-ba0d17c55232 | 2024-04-25 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Proficient Rx LP | e38f3cd2-47e5-438f-bbe3-50b578360f74 | 2024-03-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | NuCare Pharmaceuticals,Inc. | fa1da527-7a0f-8ed6-e053-6394a90a1b62 | 2024-02-09 | Warnings, Adverse reactions | Doxycycline |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.