Application 209259
- Type
- NDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYROSA | DOXYCYCLINE | TABLET;ORAL | 40MG | No | No |
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 | Sun Pharmaceutical Industries, Inc. | 829dbd3d-5c2b-47b8-96a5-423af78c93b9 | 2025-04-24 | Warnings, Adverse reactions | DOXYCYCLINE |
| ORACEA | DOXYCYCLINE | Galderma Laboratories, L.P. | aa15c93a-ff4c-447a-8a21-96da506d8997 | 2025-04-16 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Mayne Pharma Inc. | 0e6b3e17-aeee-4910-8e94-c7ac925b9cca | 2025-04-15 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Alembic Pharmaceuticals Inc. | d77e2a9c-c536-4e66-b87a-40b085737699 | 2025-04-14 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Zydus Pharmaceuticals USA Inc. | bc321932-b600-4659-a499-1853991b4ab9 | 2025-04-10 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | FOSUN PHARMA USA INC | fa3fbb09-b830-60c5-e053-6394a90a4165 | 2025-04-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| 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 | DOXYCYCLINE | Direct_Rx | 8c273efa-62ec-16b2-e053-2995a90ac41d | 2025-01-22 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | American Health Packaging | adc6ba78-8dd7-47af-a7b4-c2215557696b | 2025-01-02 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Mylan Institutional LLC | 878a1cf9-31a9-425b-910d-042ed91e98d5 | 2025-01-02 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Zydus Pharmaceuticals USA Inc. | 7ce80f6e-3c0d-4978-b626-5fd3f3ff349e | 2025-01-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Amneal Pharmaceuticals LLC | 95ba4d68-2519-4edd-b9a2-5cd2fd00b250 | 2024-12-05 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Zydus Lifesciences Limited | c886b2e4-494a-4325-abaf-981fc3d01c66 | 2024-11-28 | DOXYCYCLINE | |
| doxycycline | DOXYCYCLINE | Zydus Lifesciences Limited | aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9 | 2024-11-28 | DOXYCYCLINE | |
| DOXYCYCLINE | DOXYCYCLINE | Lupin Pharmaceuticals, Inc. | bcc65910-30d8-4807-ab61-607a56382924 | 2024-11-27 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 5f22094e-9297-4d1b-a37c-7846481b321e | 2024-08-26 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 1df9e905-d2e7-4a5a-8bd6-43f4850ba900 | 2024-08-21 | Warnings, Adverse reactions | DOXYCYCLINE |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48130 | ORIG | 2017-04-27 |