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FDA ANDA · ANDA040560
THEOPHYLLINE (ANHYDROUS)
theophylline anhydrous
Sponsor: MPP PHARMA
APPLICATION
ANDA040560
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-21
LATEST ACTION
2015-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
THEOPHYLLINEPrescription
THEOPHYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 600MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 600MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-11-20Labeling · Supplement 6 · standardAP
2006-04-21OriginalAP
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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