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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 215738

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NDA 215738 describes FLUCONAZOLE, which is a drug marketed by Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Norvium Bioscience, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, and West-ward Pharms Int, and is included in forty-two NDAs. It is available from thirty-nine suppliers. Additional details are available on the FLUCONAZOLE profile page.

The generic ingredient in FLUCONAZOLE is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for 215738

Tradename:	FLUCONAZOLE
Applicant:	Hainan Poly
Ingredient:	fluconazole
Patents:	0

Pharmacology for NDA: 215738

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 215738

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors

Suppliers and Packaging for NDA: 215738

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	215738	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-180	14335-180-10	1 BOTTLE in 1 CARTON (14335-180-10) / 35 mL in 1 BOTTLE
FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	215738	ANDA	Slate Run Pharmaceuticals	70436-227	70436-227-48	1 BOTTLE in 1 CARTON (70436-227-48) / 35 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Sep 21, 2023	TE:	AB	RLD:	No

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