Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200890

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ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE)
1%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: ISOPTO CARPINE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N200890
Product Number: 001
Approval Date: Jun 22, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE)
2%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: ISOPTO CARPINE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N200890
Product Number: 002
Approval Date: Jun 22, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE)
4%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: ISOPTO CARPINE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N200890
Product Number: 003
Approval Date: Jun 22, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information