Details for New Drug Application (NDA): 021802
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NDA 021802 describes FOCALIN XR, which is a drug marketed by Sandoz and is included in one NDA. It is available from two suppliers. Additional details are available on the FOCALIN XR profile page.
The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 021802
| Tradename: | FOCALIN XR |
| Applicant: | Sandoz |
| Ingredient: | dexmethylphenidate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021802
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 021802
Suppliers and Packaging for NDA: 021802
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NDA | Novartis Pharmaceuticals Corporation | 0078-0430 | 0078-0430-05 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05) |
| FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NDA | Novartis Pharmaceuticals Corporation | 0078-0431 | 0078-0431-05 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 26, 2005 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 26, 2005 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | May 26, 2005 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021802
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-005 | Oct 23, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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