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Generated: November 20, 2018

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Details for New Drug Application (NDA): 200890

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NDA 200890 describes ISOPTO CARPINE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from three suppliers. Additional details are available on the ISOPTO CARPINE profile page.

The generic ingredient in ISOPTO CARPINE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 200890
Tradename:ISOPTO CARPINE
Applicant:Novartis Pharms Corp
Ingredient:pilocarpine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200890
Suppliers and Packaging for NDA: 200890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890 NDA Alcon Laboratories, Inc. 0998-0203 0998-0203-15 1 BOTTLE in 1 CARTON (0998-0203-15) > 15 mL in 1 BOTTLE
ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890 NDA Alcon Laboratories, Inc. 0998-0204 0998-0204-15 1 BOTTLE in 1 CARTON (0998-0204-15) > 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength1%
Approval Date:Jun 22, 2010TE:ATRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength2%
Approval Date:Jun 22, 2010TE:ATRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength4%
Approval Date:Jun 22, 2010TE:ATRLD:Yes

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