Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020963

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TIMOLOL MALEATE (TIMOLOL MALEATE)
EQ 0.25% BASE
Marketing Status: Prescription

Active Ingredient: TIMOLOL MALEATE
Proprietary Name: TIMOLOL MALEATE
Dosage Form; Route of Administration: SOLUTION, GEL FORMING/DROPS; OPHTHALMIC
Strength: EQ 0.25% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020963
Product Number: 001
Approval Date: Oct 21, 1998
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIMOLOL MALEATE (TIMOLOL MALEATE)
EQ 0.5% BASE
Marketing Status: Prescription

Active Ingredient: TIMOLOL MALEATE
Proprietary Name: TIMOLOL MALEATE
Dosage Form; Route of Administration: SOLUTION, GEL FORMING/DROPS; OPHTHALMIC
Strength: EQ 0.5% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020963
Product Number: 002
Approval Date: Oct 21, 1998
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information