Details for New Drug Application (NDA): 075911
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The generic ingredient in LACTULOSE is lactulose. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 075911
Tradename: | LACTULOSE |
Applicant: | Xttrium Labs Inc |
Ingredient: | lactulose |
Patents: | 0 |
Pharmacology for NDA: 075911
Mechanism of Action | Acidifying Activity Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 075911
Suppliers and Packaging for NDA: 075911
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACTULOSE | lactulose | SOLUTION;ORAL | 075911 | ANDA | Xttrium Laboratories, Inc. | 0116-4005 | 0116-4005-08 | 237 mL in 1 BOTTLE (0116-4005-08) |
LACTULOSE | lactulose | SOLUTION;ORAL | 075911 | ANDA | Xttrium Laboratories, Inc. | 0116-4005 | 0116-4005-10 | 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10GM/15ML | ||||
Approval Date: | Feb 21, 2002 | TE: | AA | RLD: | No |
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