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Details for New Drug Application (NDA): 022535

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NDA 022535 describes ESBRIET, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from two suppliers. There are nineteen patents protecting this drug. Additional details are available on the ESBRIET profile page.

The generic ingredient in ESBRIET is pirfenidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for NDA: 022535

Tradename:
ESBRIET
Applicant:
Genentech Inc
Ingredient:
pirfenidone
Patents:19
Formulation / Manufacturing:see details

Pharmacology for NDA: 022535

Ingredient-typePyridones

Suppliers and Packaging for NDA: 022535

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESBRIET
pirfenidone
CAPSULE;ORAL 022535 NDA Genentech, Inc. 50242-121 50242-121-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC
ESBRIET
pirfenidone
CAPSULE;ORAL 022535 NDA Genentech, Inc. 50242-121 50242-121-02 1 BLISTER PACK in 1 CARTON (50242-121-02) > 63 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength267MG
Approval Date:Oct 15, 2014TE:RLD:Yes
Patent:7,635,707Patent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:8,592,462Patent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:8,609,701Patent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE


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