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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090456

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NDA 090456 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Dr Reddys Labs Ltd, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Vintage Pharms Llc, West-ward Pharms Int, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Apotex, Akorn Inc, Mylan Labs Ltd, and Par Sterile Products, and is included in thirty NDAs. It is available from seventeen suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 090456

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090456

Suppliers and Packaging for NDA: 090456

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090456 ANDA AvPAK 50268-581 50268-581-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-581-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-581-11)
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090456 ANDA Greenstone LLC 59762-0702 59762-0702-3 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59762-0702-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 10, 2010TE:ABRLD:No


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