Home Applications 077579 Application 077579
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CALCIPOTRIENE CALCIPOTRIENE SOLUTION;TOPICAL 0.005% 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 A077579-001 CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION / TOPICAL 2009-11-19
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcipotriene CALCIPOTRIENE Sun Pharmaceutical Industries, Inc. 277d843a-0ea9-429d-813d-49ed72dafb64 2026-07-14 Adverse reactions Name fallback Calcipotriene CALCIPOTRIENE Glenmark Pharmaceuticals Inc., USA 1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc 2026-01-23 Warnings, Adverse reactions Name fallback calcipotriene CALCIPOTRIENE Glenmark Pharmaceuticals Inc.,USA 7ec750f6-26ea-46bc-aa7b-174fd25253a2 2025-10-27 Warnings, Adverse reactions Name fallback calcipotriene CALCIPOTRIENE Northstar Rx LLC a882ef4f-603e-4421-97ae-2c78822c767a 2024-06-24 Warnings, Adverse reactions Name fallback calcipotriene CALCIPOTRIENE Mayne Pharma 26756ac7-a80c-49db-97bb-351f76ad8a71 2024-05-09 Warnings, Adverse reactions Name fallback Calcipotriene CALCIPOTRIENE Prasco Laboratories 377eafda-737c-4ba2-9ec5-61209b8814ed 2022-12-12 Warnings, Adverse reactions Name fallback Calcipotriene CALCIPOTRIENE Cosette Pharmaceuticals, Inc. 21378c25-5622-8bf7-1a8c-b05940a846a0 2022-11-15 Warnings, Adverse reactions Name fallback calcipotriene CALCIPOTRIENE Prasco Laboratories fe7cd92a-f066-4c4a-80c8-e3f929ad4181 2020-08-07 Warnings, Adverse reactions Name fallback
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.
NDC Listings For This Application# NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-732 Calcipotriene Calcipotriene Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-732 Calcipotriene Calcipotriene Akorn ANDA Current 50383-732 Calcipotriene Calcipotriene Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-732 Calcipotriene Calcipotriene Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-732 Calcipotriene Calcipotriene Akorn ANDA Current