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Details for New Drug Application (NDA): 075720

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NDA 075720 describes METIPRANOLOL, which is a drug marketed by Alcon Res Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the METIPRANOLOL profile page.

The generic ingredient in METIPRANOLOL is metipranolol hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metipranolol hydrochloride profile page.

Summary for NDA: 075720

Alcon Res Ltd
metipranolol hydrochloride
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 075720

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 075720

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metipranolol hydrochloride
SOLUTION/DROPS;OPHTHALMIC 075720 ANDA Falcon Pharmaceuticals, Ltd. 61314-447 61314-447-05 5 mL in 1 BOTTLE, PLASTIC (61314-447-05)
metipranolol hydrochloride
SOLUTION/DROPS;OPHTHALMIC 075720 ANDA Falcon Pharmaceuticals, Ltd. 61314-447 61314-447-10 10 mL in 1 BOTTLE, PLASTIC (61314-447-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Aug 6, 2001TE:ATRLD:No

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