Details for New Drug Application (NDA): 217914
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NDA 217914 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 217914
| Tradename: | LACTULOSE |
| Applicant: | Pai Holdings |
| Ingredient: | lactulose |
| Patents: | 0 |
Pharmacology for NDA: 217914
| Mechanism of Action | Acidifying Activity Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 217914
Suppliers and Packaging for NDA: 217914
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LACTULOSE | lactulose | FOR SOLUTION;ORAL | 217914 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0965 | 0121-0965-30 | 30 POUCH in 1 CARTON (0121-0965-30) / 10 g in 1 POUCH (0121-0965-01) |
| LACTULOSE | lactulose | FOR SOLUTION;ORAL | 217914 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1930 | 0121-1930-30 | 30 POUCH in 1 CARTON (0121-1930-30) / 20 g in 1 POUCH (0121-1930-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 10GM/PACKET | ||||
| Approval Date: | Mar 14, 2025 | TE: | AA | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Sep 13, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 20GM/PACKET | ||||
| Approval Date: | Mar 14, 2025 | TE: | AA | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Sep 13, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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