Details for New Drug Application (NDA): 207786
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NDA 207786 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Taro, Vistapharm Llc, Xttrium Labs Inc, Bajaj, Pai Holdings Pharm, Roxane, and Solvay, and is included in twenty-three NDAs. It is available from eighteen 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. Eighteen 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. 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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