Details for New Drug Application (NDA): 076645
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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.
Pharmacology for NDA: 076645
Mechanism of Action | Acidifying Activity Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 076645
Suppliers and Packaging for NDA: 076645
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACTULOSE | lactulose | SOLUTION;ORAL, RECTAL | 076645 | ANDA | Bajaj Medical, LLC | 61037-471 | 61037-471-02 | 236 mL in 1 BOTTLE (61037-471-02) |
LACTULOSE | lactulose | SOLUTION;ORAL, RECTAL | 076645 | ANDA | Bajaj Medical, LLC | 61037-471 | 61037-471-03 | 946 mL in 1 BOTTLE (61037-471-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 10GM/15ML | ||||
Approval Date: | Jul 28, 2003 | TE: | AA | RLD: | No |
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