Application 208381

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR1250MG/5ML (250MG/ML)NoNo

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyprogesterone CaproateHYDROXYPROGESTERONE CAPROATEEugia US LLC687bcf42-f437-42c7-8909-a91f621f55df2026-06-12Warnings, Adverse reactionsName fallback

Warnings cross-check#

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warnings

WARNINGS Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Medication should be stopped if examination reveals papilledema or retinal vascular lesions. Allergic reactions Hypersensitivity reaction to progestins have been reported. Hydroxyprogesterone caproate is contraindicated in women with a history of hypersensitivity to a progestin. Glucose tolerance Progestins may decrease glucose tolerance and the blood glucose concentration should be monitored in diabetic users.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS A. Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins. B. neuroocular lesions (e.g., retinal thrombosis and optic neuritis); nausea; vomiting; gastrointestinal symptoms (such as abdominal cramps or bloating); edema; breakthrough bleeding, spotting, or withdrawal bleeding; breast tenderness; changes in body weight (increase or decrease); headache; increase in cervical mucus; allergic rash; abscess; pain at the injection site; migraine headaches. C. chloasma or melasma, cholestatic jaundice, rise in blood pressure, mental depression, and amenorrhea during or after treatment. D. posttreatment anovulation, cystitis, hirsutism, loss of scalp hair, changes in libido, changes in appetite, dizziness, fatigue, backache, itching, or amenorrhea. E. The following laboratory tests may be affected by progestins: hepatic function (increased sulfobromophthalein retention and other tests); coagulation tests (increased in prothrombin and Factors VII, VIII, IX, and X); thyroid function tests (increase in PBI and butanol extractable protein-bound iodine, decrease in T3 uptake values. A few instances of coughing, dyspnea, constriction of the chest, and/or allergic-like reactions have occurred following hydroxyprogesterone caproate therapy; the likelihood of these occurring may be increased at higher dosage levels.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-037HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESun Pharmaceutical Industries, Inc.ANDACurrent