Details for New Drug Application (NDA): 074076
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The generic ingredient in LACTULOSE 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 074076
Tradename: | LACTULOSE |
Applicant: | Hikma |
Ingredient: | lactulose |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074076
Mechanism of Action | Acidifying Activity Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 074076
Suppliers and Packaging for NDA: 074076
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACTULOSE | lactulose | SOLUTION;ORAL | 074076 | ANDA | Akorn | 50383-356 | 50383-356-17 | 4 TRAY in 1 CASE (50383-356-17) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (50383-356-15) |
LACTULOSE | lactulose | SOLUTION;ORAL | 074076 | ANDA | Akorn | 50383-357 | 50383-357-31 | 4 TRAY in 1 CASE (50383-357-31) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 10GM/15ML | ||||
Approval Date: | Jul 3, 1995 | TE: | RLD: | No |
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