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Details for New Drug Application (NDA): 018891

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NDA 018891 describes CATAPRES-TTS-3, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. Additional details are available on the CATAPRES-TTS-3 profile page.

The generic ingredient in CATAPRES-TTS-3 is clonidine. There are twenty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the clonidine profile page.

Summary for NDA: 018891

Tradename:
CATAPRES-TTS-1
Applicant:
Boehringer Ingelheim
Ingredient:
clonidine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018891

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 018891

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CATAPRES-TTS-1
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL 018891 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0031 0597-0031-34 4 POUCH in 1 CARTON (0597-0031-34) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH
CATAPRES-TTS-1
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL 018891 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0032 0597-0032-34 4 POUCH in 1 CARTON (0597-0032-34) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Oct 10, 1984TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/24HR
Approval Date:Oct 10, 1984TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.3MG/24HR
Approval Date:Oct 10, 1984TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018891

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
CATAPRES-TTS-3
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL018891-003Oct 10, 19843,454,701► subscribe
Boehringer Ingelheim
CATAPRES-TTS-3
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL018891-003Oct 10, 19844,559,222► subscribe
Boehringer Ingelheim
CATAPRES-TTS-1
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL018891-001Oct 10, 19843,454,701► subscribe
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