Details for New Drug Application (NDA): 020615
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NDA 020615 describes DURACLON, which is a drug marketed by Mylan Institutional and is included in one NDA. It is available from one supplier. Additional details are available on the DURACLON profile page.
The generic ingredient in DURACLON is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
The generic ingredient in DURACLON is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
Summary for 020615
| Tradename: | DURACLON |
| Applicant: | Mylan Institutional |
| Ingredient: | clonidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020615
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 020615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DURACLON | clonidine hydrochloride | INJECTABLE;INJECTION | 020615 | NDA | Mylan Institutional LLC | 67457-218 | 67457-218-10 | 1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/10ML (0.1MG/ML) | ||||
| Approval Date: | Oct 2, 1996 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 27, 1999 | TE: | RLD: | Yes | |||||
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