Details for New Drug Application (NDA): 074603
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NDA 074603 describes GENERLAC, which is a drug marketed by Chartwell Rx and Morton Grove and is included in two NDAs. It is available from one supplier. Additional details are available on the GENERLAC profile page.
The generic ingredient in GENERLAC 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 GENERLAC 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 074603
| Tradename: | GENERLAC |
| Applicant: | Chartwell Rx |
| Ingredient: | lactulose |
| Patents: | 0 |
Pharmacology for NDA: 074603
| Mechanism of Action | Acidifying Activity Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Medical Subject Heading (MeSH) Categories for 074603
Suppliers and Packaging for NDA: 074603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENERLAC | lactulose | SOLUTION;ORAL, RECTAL | 074603 | ANDA | Chartwell RX, LLC | 62135-892 | 62135-892-47 | 473 mL in 1 BOTTLE (62135-892-47) |
| GENERLAC | lactulose | SOLUTION;ORAL, RECTAL | 074603 | ANDA | Chartwell RX, LLC | 62135-892 | 62135-892-94 | 946 mL in 1 BOTTLE (62135-892-94) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 10GM/15ML | ||||
| Approval Date: | Oct 31, 1996 | TE: | AA | RLD: | No | ||||
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