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 | Henry Schein, Inc | dd70368b-1949-4833-9d1e-f9f4cdacd9f3 | 2025-10-24 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Lupin Pharmaceuticals, Inc. | e0e80435-1b6a-4361-8c8a-e432f8f23a1b | 2025-10-23 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE DOXYCYCLINE | DOXYCYCLINE | Dr. Reddy's Laboratories, Inc. | c0206e91-d87f-311c-80dc-aad543d001e8 | 2025-10-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Solco Healthcare US,LLC | 99305d9a-d058-45d6-8dec-19308b1fc5a9 | 2025-09-30 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Chartwell Governmental & Specialty RX, LLC | b8486639-7eb9-4610-9cd4-0e922045d592 | 2025-09-30 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Chartwell RX LLC | 3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35 | 2025-09-30 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Piramal Critical Care Inc | fd672959-014f-8300-e053-6394a90a5ec5 | 2025-09-23 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline Hyclate | DOXYCYCLINE | Amneal Pharmaceuticals NY LLC | 49ecbf95-58e8-4f3c-b5d5-650a15d866cb | 2025-09-17 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline Hyclate | DOXYCYCLINE | Amneal Pharmaceuticals NY LLC | 79f3c026-7687-4a11-8d2e-03493531d3bf | 2025-09-10 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Strides Pharma Science Limited | d27c58a1-5c99-4007-9bc6-ad9b6fb56db8 | 2025-09-03 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | AvKARE | 3dd8c11c-aa52-9e22-e063-6294a90a5cbd | 2025-09-02 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Proficient Rx LP | 00ea3641-18da-4a6f-a779-e16075464d2b | 2025-09-01 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2bcde264-5f6f-47f6-ae2e-1b7010deacf7 | 2025-07-18 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Alembic Pharmaceuticals Inc. | a50e953d-447b-4b66-b567-04586174d3f9 | 2025-06-16 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Macleods Pharmaceuticals Limited | 10aca485-850b-4c82-bb7e-5fac2d7a62ce | 2025-06-07 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Dr.Reddys Laboratories Inc | 7a28cce1-4805-b3d1-4484-e7a49c597660 | 2025-06-06 | Warnings, Adverse reactions | DOXYCYCLINE |
| DOXYCYCLINE | DOXYCYCLINE | Lupin Pharmaceuticals, Inc. | 81c5a7fc-3fe0-40b2-bae0-c79eb0b27697 | 2025-06-04 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | b46208a2-5072-4df5-b2af-379f865545d2 | 2025-06-02 | Warnings, Adverse reactions | DOXYCYCLINE |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 2b3b3c48-eb60-400c-bdfe-50635a136c90 | 2025-05-28 | Warnings, Adverse reactions | DOXYCYCLINE |
| doxycycline | DOXYCYCLINE | Zydus Pharmaceuticals USA Inc. | fef9580d-8850-4cbb-89eb-2b4d40ee59c9 | 2025-04-26 | 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 |