Details for New Drug Application (NDA): 078992
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NDA 078992 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Adare Pharms Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Granules, Impax Labs Inc, Medicap Labs, Ph Health, Sun Pharm Inds Inc, Teva Pharms Usa, Abhai Inc, Alkem Labs Ltd, Bionpharma, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in twenty-two NDAs. It is available from fifteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.
The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 078992
| Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Applicant: | Medicap Labs |
| Ingredient: | dexmethylphenidate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078992
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 078992
Suppliers and Packaging for NDA: 078992
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078992 | ANDA | Par Pharmaceuticals, Inc. | 49884-428 | 49884-428-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-01) |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078992 | ANDA | Par Pharmaceuticals, Inc. | 49884-428 | 49884-428-10 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 23, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 23, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Nov 18, 2013 | TE: | AB | RLD: | No | ||||
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