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Generated: November 13, 2018

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Details for New Drug Application (NDA): 072344

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NDA 072344 describes ACEPHEN, which is a drug marketed by G And W Labs and is included in four NDAs. It is available from four suppliers. 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-six suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 072344
Tradename:ACEPHEN
Applicant:G And W Labs
Ingredient:acetaminophen
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 072344
Suppliers and Packaging for NDA: 072344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 072344 ANDA G&W Laboratories, Inc. 0713-0164 0713-0164-01 100 BLISTER PACK in 1 BOX (0713-0164-01) > 1 SUPPOSITORY in 1 BLISTER PACK
ACEPHEN acetaminophen SUPPOSITORY;RECTAL 072344 ANDA G&W Laboratories, Inc. 0713-0164 0713-0164-12 12 BLISTER PACK in 1 BOX (0713-0164-12) > 1 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUPPOSITORY;RECTALStrength325MG
Approval Date:Mar 27, 1992TE:RLD:No

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