Details for New Drug Application (NDA): 213473
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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 213473
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Dr Reddys |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213473
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 213473
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213473 | ANDA | Dr.Reddys Laboratories Inc | 43598-438 | 43598-438-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-438-01) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213473 | ANDA | Dr.Reddys Laboratories Inc | 43598-439 | 43598-439-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-439-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 18MG | ||||
Approval Date: | Jul 29, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 27MG | ||||
Approval Date: | Jul 29, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 36MG | ||||
Approval Date: | Jul 29, 2020 | TE: | AB | RLD: | No |
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