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Details for New Drug Application (NDA): 089987

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NDA 089987 describes BUTAPAP, which is a drug marketed by Mikart and is included in two NDAs. It is available from five suppliers. Additional details are available on the BUTAPAP profile page.

The generic ingredient in BUTAPAP is acetaminophen; butalbital. There are sixty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for NDA: 089987

Tradename:
BUTAPAP
Applicant:
Mikart
Ingredient:
acetaminophen; butalbital
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 089987

Ingredient-typeBarbiturates

Suppliers and Packaging for NDA: 089987

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTAPAP
acetaminophen; butalbital
TABLET;ORAL 089987 ANDA Qualitest Pharmaceuticals 0603-2540 0603-2540-21 100 TABLET in 1 BOTTLE (0603-2540-21)
BUTAPAP
acetaminophen; butalbital
TABLET;ORAL 089987 ANDA Marnel Pharmaceuticals, Inc. 0682-1400 0682-1400-01 100 TABLET in 1 BOTTLE, PLASTIC (0682-1400-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Oct 26, 1992TE:AARLD:Yes


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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.

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