Details for New Drug Application (NDA): 209517
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NDA 209517 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, Vistapharm, Xttrium Labs Inc, Bajaj, Pai Holdings Pharm, Roxane, and Solvay, and is included in twenty-two NDAs. It is available from seventeen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 209517
| Tradename: | LACTULOSE |
| Applicant: | Chartwell Rx |
| Ingredient: | lactulose |
| Patents: | 0 |
Pharmacology for NDA: 209517
| Mechanism of Action | Acidifying Activity Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 209517
Suppliers and Packaging for NDA: 209517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LACTULOSE | lactulose | SOLUTION;ORAL | 209517 | ANDA | Chartwell RX, LLC | 62135-002 | 62135-002-24 | 2 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51) |
| LACTULOSE | lactulose | SOLUTION;ORAL | 209517 | ANDA | Chartwell RX, LLC | 62135-002 | 62135-002-37 | 237 mL in 1 PACKAGE (62135-002-37) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10GM/15ML | ||||
| Approval Date: | Nov 23, 2018 | TE: | AA | RLD: | No | ||||
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