Details for New Drug Application (NDA): 022500
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NDA 022500 describes NEXICLON XR, which is a drug marketed by Rosemont and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the NEXICLON XR profile page.
The generic ingredient in NEXICLON XR is clonidine. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the clonidine profile page.
The generic ingredient in NEXICLON XR is clonidine. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the clonidine profile page.
Summary for 022500
| Tradename: | NEXICLON XR |
| Applicant: | Rosemont |
| Ingredient: | clonidine |
| Patents: | 2 |
Pharmacology for NDA: 022500
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 022500
Suppliers and Packaging for NDA: 022500
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXICLON XR | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500 | NDA AUTHORIZED GENERIC | TruPharma, LLC | 52817-375 | 52817-375-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30) |
| NEXICLON XR | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500 | NDA AUTHORIZED GENERIC | PALMETTO PHARMACEUTICALS INC. | 68134-603 | 68134-603-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 0.17MG BASE | ||||
| Approval Date: | Dec 3, 2009 | TE: | RLD: | No | |||||
| Patent: | 8,337,890 | Patent Expiration: | Apr 17, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,623,409 | Patent Expiration: | Sep 8, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 0.26MG BASE | ||||
| Approval Date: | Dec 3, 2009 | TE: | RLD: | No | |||||
| Patent: | 8,337,890 | Patent Expiration: | Apr 17, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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