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Generated: April 26, 2017

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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 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-five drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

Summary for NDA: 072237

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 072237

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPPOSITORY;RECTAL 072237 ANDA G&W Laboratories, Inc. 0713-0165 0713-0165-01 100 SUPPOSITORY in 1 BOX (0713-0165-01)
SUPPOSITORY;RECTAL 072237 ANDA G&W Laboratories, Inc. 0713-0165 0713-0165-05 500 SUPPOSITORY in 1 BOX (0713-0165-05)

Summary for product number 001

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

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