Details for New Drug Application (NDA): 214134
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The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Seventeen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 214134
Tradename: | LISDEXAMFETAMINE DIMESYLATE |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | lisdexamfetamine dimesylate |
Patents: | 0 |
Pharmacology for NDA: 214134
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 214134
Suppliers and Packaging for NDA: 214134
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 214134 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-083 | 57664-083-88 | 100 TABLET, CHEWABLE in 1 BOTTLE (57664-083-88) |
LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 214134 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-084 | 57664-084-88 | 100 TABLET, CHEWABLE in 1 BOTTLE (57664-084-88) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 25, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 20MG | ||||
Approval Date: | Aug 25, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 30MG | ||||
Approval Date: | Aug 25, 2023 | TE: | AB | RLD: | No |
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