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Generated: January 20, 2018

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Details for New Drug Application (NDA): 040100

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NDA 040100 describes LORTAB, which is a drug marketed by Ucb Inc and is included in two NDAs. Additional details are available on the LORTAB profile page.

The generic ingredient in LORTAB is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040100
Tradename:LORTAB
Applicant:Ucb Inc
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;10MG
Approval Date:Jan 26, 1996TE:RLD:No

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