Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200744

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NDA 200744 describes TACROLIMUS, which is a drug marketed by Accord Hlthcare, Belcher Pharms Llc, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Hospira Inc, Fougera Pharms Inc, and Glenmark Pharms Ltd, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the TACROLIMUS profile page.

The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 200744
Tradename:TACROLIMUS
Applicant:Fougera Pharms Inc
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200744
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 200744
Suppliers and Packaging for NDA: 200744
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus OINTMENT;TOPICAL 200744 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0416 0168-0416-30 1 TUBE in 1 CARTON (0168-0416-30) > 30 g in 1 TUBE
TACROLIMUS tacrolimus OINTMENT;TOPICAL 200744 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0416 0168-0416-60 1 TUBE in 1 CARTON (0168-0416-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.03%
Approval Date:Sep 9, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Sep 9, 2014TE:ABRLD:No

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