Details for New Drug Application (NDA): 207786
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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 207786
Tradename: | LACTULOSE |
Applicant: | Apozeal Pharms |
Ingredient: | lactulose |
Patents: | 0 |
Pharmacology for NDA: 207786
Mechanism of Action | Acidifying Activity Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 207786
Suppliers and Packaging for NDA: 207786
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACTULOSE | lactulose | SOLUTION;ORAL | 207786 | ANDA | APOZEAL PHARMACEUTICALS INC | 83745-405 | 83745-405-08 | 237 mL in 1 BOTTLE (83745-405-08) |
LACTULOSE | lactulose | SOLUTION;ORAL | 207786 | ANDA | APOZEAL PHARMACEUTICALS INC | 83745-405 | 83745-405-16 | 473 mL in 1 BOTTLE (83745-405-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10GM/15ML | ||||
Approval Date: | Jun 11, 2018 | TE: | AA | RLD: | No |
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