Details for New Drug Application (NDA): 090503
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The generic ingredient in LACTULOSE is lactulose. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 090503
Tradename: | LACTULOSE |
Applicant: | Fresenius Kabi |
Ingredient: | lactulose |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090503
Mechanism of Action | Acidifying Activity Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 090503
Suppliers and Packaging for NDA: 090503
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACTULOSE | lactulose | SOLUTION;ORAL | 090503 | ANDA | Actavis Pharma, Inc. | 45963-439 | 45963-439-63 | 237 mL in 1 BOTTLE (45963-439-63) |
LACTULOSE | lactulose | SOLUTION;ORAL | 090503 | ANDA | Actavis Pharma, Inc. | 45963-439 | 45963-439-65 | 946 mL in 1 BOTTLE (45963-439-65) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10GM/15ML | ||||
Approval Date: | Jan 25, 2012 | TE: | AA | RLD: | No |
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