Details for New Drug Application (NDA): 091601
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NDA 091601 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in sixty-nine NDAs. It is available from thirty-five suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.
The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 091601
| Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
| Applicant: | Tris Pharma Inc |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091601
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 091601
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | SOLUTION;ORAL | 091601 | ANDA | Tris Pharma Inc | 27808-058 | 27808-058-01 | 500 mL in 1 BOTTLE, PLASTIC (27808-058-01) |
| METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | SOLUTION;ORAL | 091601 | ANDA | Tris Pharma Inc | 27808-059 | 27808-059-01 | 500 mL in 1 BOTTLE, PLASTIC (27808-059-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Jul 23, 2010 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
| Approval Date: | Jul 23, 2010 | TE: | AA | RLD: | No | ||||
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