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FDA ANDA · ANDA090311

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Sponsor: BEDFORD LABS

APPLICATION
ANDA090311
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)

Products

MYCOPHENOLATE MOFETIL HYDROCHLORIDENone (Tentative Approval)
MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG · INJECTABLE · INJECTION

Approval history

2010-09-30OriginalTA
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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