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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040165

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NDA 040165 describes AKPENTOLATE, which is a drug marketed by Akorn and is included in two NDAs. It is available from two suppliers. Additional details are available on the AKPENTOLATE profile page.

The generic ingredient in AKPENTOLATE is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
Summary for 040165
Ingredient:cyclopentolate hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040165
Suppliers and Packaging for NDA: 040165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040165 ANDA Akorn, Inc. 17478-097 N 17478-097-10
AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040165 ANDA Akorn, Inc. 17478-097 N 17478-097-12

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength2%
Approval Date:Jan 13, 1997TE:RLD:No

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