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Last Updated: September 24, 2020

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Details for New Drug Application (NDA): 204398

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NDA 204398 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Perrigo Pharma Intl, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the PILOCARPINE HYDROCHLORIDE profile page.

The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 204398
Tradename:PILOCARPINE HYDROCHLORIDE
Applicant:Akorn Inc
Ingredient:pilocarpine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204398
Suppliers and Packaging for NDA: 204398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398 ANDA Akorn, Inc. 17478-223 17478-223-12 1 BOTTLE, DROPPER in 1 CARTON (17478-223-12) > 15 mL in 1 BOTTLE, DROPPER
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398 ANDA Akorn, Inc. 17478-224 17478-224-12 1 BOTTLE, DROPPER in 1 CARTON (17478-224-12) > 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength1%
Approval Date:Sep 27, 2017TE:ATRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength2%
Approval Date:Sep 27, 2017TE:ATRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength4%
Approval Date:Sep 27, 2017TE:ATRLD:No

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