Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079247
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.398GM;1.102GM TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/2011 ORIG-1 Approval

Label is not available on this site.

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

TABLET;ORAL; 0.398GM;1.102GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.398GM;1.102GM TABLET;ORAL Prescription No AB 079247 NOVEL LABS INC
OSMOPREP SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.398GM;1.102GM TABLET;ORAL Prescription Yes AB 021892 SALIX PHARMS

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