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Mycophenolate mofetil hydrochloride - Generic Drug Details

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Mycophenolate mofetil hydrochloride is the generic ingredient in one branded drug marketed by Roche Palo and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are thirty-five drug master file entries for mycophenolate mofetil hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mycophenolate mofetil hydrochloride

Tradenames:1
Patents:0
Applicants:1
NDAs:1
Drug Master File Entries: see list35
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: mycophenolate mofetil hydrochloride

Tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION500MG

Clinical Trials for: mycophenolate mofetil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 1998RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: mycophenolate mofetil hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 19984,753,935<disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 19985,543,408<disabled>
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