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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 Pharms and Morton Grove 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. Nineteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for NDA: 074603

Tradename:
GENERLAC
Applicant:
Morton Grove Pharms
Ingredient:
lactulose
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 1 BOTTLE, PLASTIC in 1 CARTON (60432-038-16) > 473 mL in 1 BOTTLE, PLASTIC
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)

Summary for product number 001

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


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