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Details for New Drug Application (NDA): 075993

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NDA 075993 describes LACTULOSE, which is a drug marketed by Morton Grove, Fresenius Kabi, Solvay, Apotex Inc, Cumberland Pharms, Pharm Assoc, Ani Pharms, Paco, Vistapharm, Bio-pharm Inc, Hi Tech Pharma, Roxane, and Vintage Pharms, and is included in twenty NDAs. It is available from nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for NDA: 075993

Vintage Pharms
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 075993

Suppliers and Packaging for NDA: 075993

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 075993 ANDA Qualitest Pharmaceuticals 0603-1378 0603-1378-56 236 mL in 1 BOTTLE (0603-1378-56)
SOLUTION;ORAL 075993 ANDA Qualitest Pharmaceuticals 0603-1378 0603-1378-58 473 mL in 1 BOTTLE (0603-1378-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10GM/15ML
Approval Date:Jul 26, 2001TE:AARLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.