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 Hyclate | DOXYCYCLINE HYCLATE | Chartwell RX, LLC | b3294889-e8f8-42f1-9bd0-13d87572997a | 2025-04-15 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE | DOXYCYCLINE | Mayne Pharma Inc. | 0e6b3e17-aeee-4910-8e94-c7ac925b9cca | 2025-04-15 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 65cac0b6-3550-48cf-bffa-cf42443c2731 | 2025-04-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Alembic Pharmaceuticals Inc. | d77e2a9c-c536-4e66-b87a-40b085737699 | 2025-04-14 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | cd2ab9b8-9619-4199-8a5d-83377b3274d1 | 2025-04-14 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Zydus Pharmaceuticals USA Inc. | bc321932-b600-4659-a499-1853991b4ab9 | 2025-04-10 | Warnings, Adverse reactions | Doxycycline |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Coupler LLC | 325d5331-d48e-1bc4-e063-6394a90a65b9 | 2025-04-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Sun Pharmaceutical Industries, Inc. | bff3f426-44fc-4dbf-96df-df44011103e8 | 2025-04-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Epic Pharma, LLC | 2b402587-8ecc-4fea-83ad-8071345b6356 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Actavis Pharma, Inc. | c2b08332-3256-4658-965a-ede3d973a388 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE | DOXYCYCLINE | FOSUN PHARMA USA INC | fa3fbb09-b830-60c5-e053-6394a90a4165 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | e726157e-ce44-4df3-8161-7016700dd751 | 2025-03-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE | Hikma Pharmaceuticals USA Inc. | 2aa835bd-6fac-46b8-9716-9622fb550c8f | 2025-03-25 | Warnings, Adverse reactions | Doxycycline |
| DOXYCYCLINE | DOXYCYCLINE | Gland Pharma Limited | 6a5780a9-4548-427c-972a-ef49fdcbc84d | 2025-03-20 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | EPIC PHARMA, LLC | b3cd7b44-db40-4ce5-895e-d4c85a0068ae | 2025-03-19 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 861b71f3-37e8-4596-838c-c8dad8ed5ff4 | 2025-02-04 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 942ab6dd-e355-41da-b139-72cc8b7a2667 | 2025-02-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 5b4390ed-a0ec-4ef8-864c-8a33a83653f9 | 2025-01-31 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Redpharm Drug, Inc. | 09d19663-a8b9-0c3f-e063-6394a90aa446 | 2025-01-23 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Redpharm Drug | 1a3c713f-bc4f-4848-e063-6394a90a0272 | 2025-01-23 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.