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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 Alcon Res 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 NDA: 200890

Tradename:
ISOPTO CARPINE
Applicant:
Alcon Res
Ingredient:
pilocarpine hydrochloride
Patents:0
Therapeutic Class:Dental and Oral Agents
Ophthalmic Agents
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength1%
Approval Date:Jun 22, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength2%
Approval Date:Jun 22, 2010TE:RLD:No

Summary for product number 003

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


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