Details for New Drug Application (NDA): 017657
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The generic ingredient in CEPHULAC is lactulose. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 017657
Tradename: | CEPHULAC |
Applicant: | Sanofi Aventis Us |
Ingredient: | lactulose |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 017657
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Expired US Patents for NDA 017657
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | CEPHULAC | lactulose | SOLUTION;ORAL, RECTAL | 017657-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | CEPHULAC | lactulose | SOLUTION;ORAL, RECTAL | 017657-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | CEPHULAC | lactulose | SOLUTION;ORAL, RECTAL | 017657-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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