Application 209259

Type
NDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XYROSADOXYCYCLINETABLET;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Matched openFDA labels page 5 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEBryant Ranch Prepack5f989cc1-48ae-41bb-b297-2f8c83760b6d2024-07-15Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINELannett Company, Inc.4999bbd9-44ed-4749-9730-be2337bdf4902024-07-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DOXYCYCLINEDOXYCYCLINEAlembic Pharmaceuticals Limited8e78dc54-8322-435d-8879-4bfe37f1b98c2024-07-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINELupin Pharmaceuticals,Inc.6512bf22-c211-4127-a8c8-2419656580f62024-01-30Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEProficient Rx LPb83c4c4b-2885-43e7-b1c9-0b3bbf75528d2023-10-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEAsclemed USA, Inc.f33ae6f5-bdb6-4c15-9e62-6180433bb1fb2023-05-04Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEAlembic Pharmaceuticals Limited3dfa486c-4665-4882-93ac-9259708f899c2023-01-27Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEZydus Lifesciences Limited6ae11b4e-1c13-440b-a050-d76e062b0f922022-11-05Name fallback
generic name: DOXYCYCLINE
Doxycycline HyclateDOXYCYCLINEProficient Rx LPe2151005-fb4a-485d-88ad-b44c4594d5792022-06-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
Doxy 100DOXYCYCLINEFresenius Kabi USA, LLCb256babb-1bba-4b0c-8837-d13ba3af76592021-02-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
Doxy 100DOXYCYCLINEFresenius Kabi USA, LLCa7b754e2-a028-469d-ba95-8412ef03ab0a2021-02-02Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
Doxy 100DOXYCYCLINEFresenius Kabi USA, LLCb0894010-39bd-459f-8563-cf83343105ee2020-06-04Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEProficient Rx LPf3ba6c30-ada3-4a57-9ff8-30558202b9aa2019-11-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries Inc.8224b9c5-5c4b-4dda-bc58-47b6604c28842018-08-06Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48130ORIG2017-04-27