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Reference ID: 3115694

Reference ID: 3115694

www.accessdata.fda.gov

Reference ID: 3115694 . Allergic Urticaria. • Pregnancy [see Use in Specific Populations (8.1)] • Nursing [see Use in Specific Populations (8.3)] • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines . WARNINGS AND PRECAUTIONS . Coadministration With Other Drug Products for Weight Loss

  Reference, Reference id, 3115694

Reference ID: 3058238

Reference ID: 3058238

www.accessdata.fda.gov

112 . 6.2 Postmarketing Experience : 113 : The following adverse reactions have been identified during post-approval use of : 114 (Reference ID: 3058238

  Reference, Reference id, 3058238

Reference ID: 3433133

Reference ID: 3433133

www.accessdata.fda.gov

Reference ID: 3433133 . 5.4 Genital Mycotic Infections . FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections [see Adverse Reactions (6.1)]. Monitor and treat appropriately.

  Reference, Reference id, 3433133

Reference ID: 3324257 - Food and Drug Administration

Reference ID: 3324257 - Food and Drug Administration

www.accessdata.fda.gov

Page 4 monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent peripheral lymph nodes, abnormal bone growth, and decreased neonatal growth [see Use in Specific Populations (8.1) and (8.7)].

  Administration, Drug, Food and drug administration, Food, Reference, Reference id, 3324257

Reference ID: 3537640 - Food and Drug Administration

Reference ID: 3537640 - Food and Drug Administration

www.accessdata.fda.gov

C-tavaborole solution, tavaborole conjugates and metabolites were shown to be excreted primarily in the urine. The pharmacokinetics of tavaborole was investigated in 24 subjects with distal subungual onychomycosis

  Administration, Drug, Food and drug administration, Food, Reference, Onychomycosis, Reference id, 3537640

Reference ID: 3075879 - LEO Pharma

Reference ID: 3075879 - LEO Pharma

www.leo-pharma.us

FULL PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE . Picato® gel is indicated for the topical treatment of actinic keratosis.. 2 DOSAGE AND ADMINISTRATION . For topical use only; Picato® gel is not for oral, ophthalmic, or intravaginal use.. For …

  Reference, Atopic, Reference id, 3075879

Reference ID: 4030092 - Food and Drug Administration

Reference ID: 4030092 - Food and Drug Administration

www.accessdata.fda.gov

Dose . Starting Dose . 600 mg twice daily (two 300 mg tablets) First Dose Reduction 500 mg twice daily (one 300 mg tablet . and : one 200 mg tablet) Second Dose Reduction

  Drug, Food and drug administration, Food, Reference, Reference id, 4030092

Reference ID: 2939597 - Food and Drug Administration

Reference ID: 2939597 - Food and Drug Administration

www.accessdata.fda.gov

1 INDICATIONS AND USAGE • Fusilev ® is a folate analog. • Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma.

  Administration, Drug, Food and drug administration, Food, Reference, Reference id, 2939597

Reference ID: 3366104 - ZEVALIN® (ibritumomab …

Reference ID: 3366104 - ZEVALIN® (ibritumomab

www.zevalin.com

full prescribing information warning: serious infusion reactions, prolonged and severe cytopenias, and severe cutaneous and mucocutaneous reactions

  Reference, Reference id, Ibritumomab, 3366104

Reference ID: 4090621 - Home - Radius

Reference ID: 4090621 - Home - Radius

radiuspharm.com

2.2 Administration Instructions • Administer TYMLOS as a subcutaneous injection into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same

  Reference, Reference id, 4090621

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