Home Applications 210707 Application 210707
Type ANDA
Sponsor ABHAI LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 URSODIOL URSODIOL CAPSULE;ORAL 300MG No No
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210707-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A210707-001 AB
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Ursodiol capsules until a clinical evaluation has been conducted.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: GALLSTONE DISSOLUTION Ursodiol 8 - 10 mg/kg/day (N = 155) Placebo (N = 159) N (%) N (%) Body as a Whole Allergy 8 (5.2) 7 (4.4) Chest Pain 5 (3.2) 10 (6.3) Fatigue 7 (4.5) 8 (5.0) Infection Viral 30 (19.4) 41 (25.8) Digestive System Abdominal Pain 67 (43.2) 70 (44.0) Cholecystitis 8 (5.2) 7 (4.4) Constipation 15 (9.7) 14 (8.8) Diarrhea 42 (27.1) 34 (21.4) Dyspepsia 26 (16.8) 18 (11.3) Flatulence 12 (7.7) 12 (7.5) Gastrointestinal Disorder 6 (3.9) 8 (5.0) Nausea 22 (14.2) 27 (17.0) Vomiting 15 (9.7) 11 (6.9) Musculoskeletal System Arthralgia 12 (7.7) 24 (15.1) Arthritis 9 (5.8) 4 (2.5) Back Pain 11 (7.1) 18 (11.3) Myalgia 9 (5.8) 9 (5.7) Nervous System Headache 28 (18.1) 34 (21.4) Insomnia 3 (1.9) 8 (5.0) Respiratory System Bronchitis 10 (6.5) 6 (3.8) Coughing 11 (7.1) 7 (4.4) Pharyngitis 13 (8.4) 5 (3.1) Rhinitis 8 (5.2) 11 (6.9) Sinusitis 17 (11.0) 18 (11.3) Upper Respiratory Tract Infection 24 (15.5) 21 (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION Ursodiol 600 mg (N = 322) Placebo (N = 325) N (%) N (%) Body as a Whole Fatigue 25 (7.8) 33 (10.2) Infection Viral 29 (9.0) 29 (8.9) Influenza-like Symptoms 21 (6.5) 19 (5.8) Digestive System Abdominal Pain 20 (6.2) 39 (12.0) Constipation 85 (26.4) 72 (22.2) Diarrhea 81 (25.2) 68 (20.9) Flatulence 15 (4.7) 24 (7.4) Nausea 56 (17.4) 43 (13.2) Vomiting 44 (13.7) 44 (13.5) Musculoskeletal System Back Pain 38 (11.8) 21 (6.5) Musculoskeletal pain 19 (5.9) 15 (4.6) Nervous System Dizziness 53 (16.5) 42 (12.9) Headache 80 (24.8) 78 (24.0) Respiratory System Pharyngitis 10 (3.1) 19 (5.8) Sinusitis 17 (5.3) 18 (5.5) Upper Respiratory Tract Infection 40 (12.4) 35 (10.8) Skin and Appendages Alopecia 17 (5.3) 8 (2.5) Urogenital System Dysmenorrhea 18 (5.6) 19 (5.8)
adverse reactions table Ursodiol8 - 10 mg/kg/day(N = 155)Placebo(N = 159) N(%)N(%)Body as a WholeAllergy8(5.2)7(4.4)Chest Pain5(3.2)10(6.3)Fatigue7(4.5)8(5.0)Infection Viral30(19.4)41(25.8)Digestive SystemAbdominal Pain67(43.2)70(44.0)Cholecystitis8(5.2)7(4.4)Constipation15(9.7)14(8.8)Diarrhea42(27.1)34(21.4)Dyspepsia26(16.8)18(11.3)Flatulence12(7.7)12(7.5)Gastrointestinal Disorder6(3.9)8(5.0)Nausea22(14.2)27(17.0)Vomiting15(9.7)11(6.9)Musculoskeletal SystemArthralgia12(7.7)24(15.1)Arthritis9(5.8)4(2.5)Back Pain11(7.1)18(11.3)Myalgia9(5.8)9(5.7)NervousSystemHeadache28(18.1)34(21.4)Insomnia3(1.9)8(5.0)Respiratory SystemBronchitis10(6.5)6(3.8)Coughing11(7.1)7(4.4)Pharyngitis13(8.4)5(3.1)Rhinitis8(5.2)11(6.9)Sinusitis17(11.0)18(11.3)Upper RespiratoryTract Infection24(15.5)21(13.2)Urogenital SystemUrinary Tract Infection10(6.5)7(4.4)
NDC Listings For This Application# NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10702-237 Ursodiol Ursosiol KVK-Tech, Inc. ANDA Current 10702-237 Ursodiol Ursosiol KVK-Tech, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-871 Ursodiol Ursosiol PD-Rx Pharmaceuticals, Inc. ANDA Current