Details for New Drug Application (NDA): 205135
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The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 205135
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205135
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 205135
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205135 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-606 | 57664-606-88 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-606-88) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205135 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-607 | 57664-607-88 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-607-88) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 18MG | ||||
Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 27MG | ||||
Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 36MG | ||||
Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No |
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