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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090502

LACTULOSE (LACTULOSE)
10GM/15ML
Marketing Status: Prescription
Active Ingredient: LACTULOSE
Proprietary Name: LACTULOSE
Dosage Form; Route of Administration: SOLUTION; ORAL, RECTAL
Strength: 10GM/15ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A090502
Product Number: 001
Approval Date: Jan 25, 2012
Applicant Holder Full Name: FRESENIUS KABI AUSTRIA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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