Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212942

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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: No
Reference Standard: No
TE Code: AB
Application Number: A212942
Product Number: 001
Approval Date: Oct 22, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
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: No
Reference Standard: No
TE Code: AB
Application Number: A212942
Product Number: 002
Approval Date: Oct 22, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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