You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076658


✉ Email this page to a colleague

« Back to Dashboard


NDA 076658 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 Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, 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 076658
Tradename:FLUCONAZOLE
Applicant:Dr Reddys Labs Inc
Ingredient:fluconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCONAZOLE fluconazole TABLET;ORAL 076658 ANDA Major Pharmaceuticals 0904-6500 0904-6500-06 50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACK
FLUCONAZOLE fluconazole TABLET;ORAL 076658 ANDA Major Pharmaceuticals 0904-6500 0904-6500-61 100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 29, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 29, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 29, 2004TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.