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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079247
Company: NOVEL LABS INC

Products on ANDA 079247

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079247

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.

Therapeutic Equivalents for ANDA 079247

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

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