Details for New Drug Application (NDA): 075911
✉ Email this page to a colleague
NDA 075911 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Pai Holdings, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Pharmobedient, Taro, Vistapharm Llc, Bajaj, Pai Holdings Pharm, Roxane, Sciegen Pharms Inc, and Solvay, and is included in twenty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the LACTULOSE profile page.
The generic ingredient in LACTULOSE is lactulose. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lactulose profile page.
The generic ingredient in LACTULOSE is lactulose. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 075911
| Tradename: | LACTULOSE |
| Applicant: | Pharmobedient |
| 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 | ||||
Complete Access Available with Subscription
