Details for New Drug Application (NDA): 018891
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NDA 018891 describes CATAPRES-TTS-3, which is a drug marketed by Lavipharm 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-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clonidine profile page.
The generic ingredient in CATAPRES-TTS-3 is clonidine. There are twenty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clonidine profile page.
Summary for 018891
| Tradename: | CATAPRES-TTS-3 |
| Applicant: | Lavipharm |
| Ingredient: | clonidine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018891
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 018891
Suppliers and Packaging for NDA: 018891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CATAPRES-TTS-1 | clonidine | SYSTEM;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 / 1 d in 1 PATCH |
| CATAPRES-TTS-1 | clonidine | SYSTEM;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 / 1 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.1MG/24HR | ||||
| Approval Date: | Oct 10, 1984 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.2MG/24HR | ||||
| Approval Date: | Oct 10, 1984 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.3MG/24HR | ||||
| Approval Date: | Oct 10, 1984 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018891
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lavipharm | CATAPRES-TTS-2 | clonidine | SYSTEM;TRANSDERMAL | 018891-002 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| Lavipharm | CATAPRES-TTS-1 | clonidine | SYSTEM;TRANSDERMAL | 018891-001 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| Lavipharm | CATAPRES-TTS-1 | clonidine | SYSTEM;TRANSDERMAL | 018891-001 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| Lavipharm | CATAPRES-TTS-3 | clonidine | SYSTEM;TRANSDERMAL | 018891-003 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| Lavipharm | CATAPRES-TTS-3 | clonidine | SYSTEM;TRANSDERMAL | 018891-003 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| Lavipharm | CATAPRES-TTS-2 | clonidine | SYSTEM;TRANSDERMAL | 018891-002 | Oct 10, 1984 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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