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Last Updated: June 21, 2021

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Details for New Drug Application (NDA): 018060


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NDA 018060 describes ACEPHEN, which is a drug marketed by Cosette and is included in four NDAs. It is available from one supplier. Additional details are available on the ACEPHEN profile page.

The generic ingredient in ACEPHEN is acetaminophen. There are sixty-six drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 018060
Tradename:ACEPHEN
Applicant:Cosette
Ingredient:acetaminophen
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018060
Suppliers and Packaging for NDA: 018060
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 018060 NDA Cosette Pharmaceuticals, Inc. 0713-0118 0713-0118-01 100 SUPPOSITORY in 1 BOX (0713-0118-01)
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 018060 NDA Cosette Pharmaceuticals, Inc. 0713-0118 0713-0118-12 12 SUPPOSITORY in 1 BOX (0713-0118-12)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUPPOSITORY;RECTALStrength120MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength650MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength325MG
Approval Date:Dec 18, 1986TE:RLD:No

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