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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 072237

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NDA 072237 describes ACEPHEN, which is a drug marketed by Acp Nimble 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. Sixty-three suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 072237
Applicant:Acp Nimble
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 072237
Suppliers and Packaging for NDA: 072237
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 072237 ANDA Cosette Pharmaceuticals, Inc. 0713-0165 0713-0165-01 100 SUPPOSITORY in 1 BOX (0713-0165-01)
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 072237 ANDA Cosette Pharmaceuticals, Inc. 0713-0165 0713-0165-05 500 SUPPOSITORY in 1 BOX (0713-0165-05)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUPPOSITORY;RECTALStrength650MG
Approval Date:Mar 27, 1992TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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