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FDA ANDA · ANDA079247
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
Sponsor: NOVEL LABS INC
APPLICATION
ANDA079247
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-30
LATEST ACTION
2011-12-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATEPrescription
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.398GM, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.102GM · TABLET · ORAL
Approval history
2011-12-30OriginalAP
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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