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Generated: November 12, 2018

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Details for New Drug Application (NDA): 074603

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NDA 074603 describes GENERLAC, which is a drug marketed by Morton Grove and Wockhardt Bio Ag and is included in two NDAs. It is available from one supplier. Additional details are available on the GENERLAC profile page.

The generic ingredient in GENERLAC is lactulose. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 074603
Tradename:GENERLAC
Applicant:Wockhardt Bio Ag
Ingredient:lactulose
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074603
Medical Subject Heading (MeSH) Categories for 074603
Suppliers and Packaging for NDA: 074603
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENERLAC lactulose SOLUTION;ORAL, RECTAL 074603 ANDA Morton Grove Pharmaceuticals, Inc. 60432-038 60432-038-16 473 mL in 1 BOTTLE, PLASTIC (60432-038-16)
GENERLAC lactulose SOLUTION;ORAL, RECTAL 074603 ANDA Morton Grove Pharmaceuticals, Inc. 60432-038 60432-038-64 1892 mL in 1 BOTTLE, PLASTIC (60432-038-64)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength10GM/15ML
Approval Date:Oct 31, 1996TE:AARLD:No

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