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Generated: November 20, 2018

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Details for New Drug Application (NDA): 021756

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NDA 021756 describes MACUGEN, which is a drug marketed by Valeant Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the MACUGEN profile page.

The generic ingredient in MACUGEN is pegaptanib sodium. One supplier is listed for this compound. Additional details are available on the pegaptanib sodium profile page.
Summary for 021756
Tradename:MACUGEN
Applicant:Valeant Pharms Llc
Ingredient:pegaptanib sodium
Patents:0
Pharmacology for NDA: 021756
Suppliers and Packaging for NDA: 021756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MACUGEN pegaptanib sodium INJECTABLE;INTRAVITREAL 021756 NDA Bausch & Lomb Incorporated 68782-001 68782-001-02 1 SYRINGE in 1 CARTON (68782-001-02) > .09 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVITREALStrengthEQ 0.3MG ACID/0.09ML
Approval Date:Dec 17, 2004TE:RLD:Yes

Expired US Patents for NDA 021756

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Llc MACUGEN pegaptanib sodium INJECTABLE;INTRAVITREAL 021756-001 Dec 17, 2004 ➤ Sign Up ➤ Sign Up
Valeant Pharms Llc MACUGEN pegaptanib sodium INJECTABLE;INTRAVITREAL 021756-001 Dec 17, 2004 ➤ Sign Up ➤ Sign Up
Valeant Pharms Llc MACUGEN pegaptanib sodium INJECTABLE;INTRAVITREAL 021756-001 Dec 17, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Cipla
Boehringer Ingelheim
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Argus Health
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Accenture

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