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 | 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 | DOXYCYCLINE | NuCare Pharmaceuticals,Inc. | fa1da527-7a0f-8ed6-e053-6394a90a1b62 | 2024-02-09 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Proficient Rx LP | c707566b-dbc7-4dac-bad1-952f2f4d6845 | 2024-02-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Lupin Pharmaceuticals,Inc. | 6512bf22-c211-4127-a8c8-2419656580f6 | 2024-01-30 | Warnings, Adverse reactions | DOXYCYCLINE |
| 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 | DOXYCYCLINE | Alembic Pharmaceuticals Limited | 3dfa486c-4665-4882-93ac-9259708f899c | 2023-01-27 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Zydus Lifesciences Limited | 6ae11b4e-1c13-440b-a050-d76e062b0f92 | 2022-11-05 | DOXYCYCLINE | |
| Doxycycline Hyclate | DOXYCYCLINE | Proficient Rx LP | e2151005-fb4a-485d-88ad-b44c4594d579 | 2022-06-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | b256babb-1bba-4b0c-8837-d13ba3af7659 | 2021-02-17 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | a7b754e2-a028-469d-ba95-8412ef03ab0a | 2021-02-02 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | b0894010-39bd-459f-8563-cf83343105ee | 2020-06-04 | Warnings, Adverse reactions | DOXYCYCLINE |
| 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.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48130 | ORIG | 2017-04-27 |