Details for New Drug Application (NDA): 218850
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NDA 218850 describes LISDEXAMFETAMINE DIMESYLATE, which is a drug marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Elite Labs Inc, Granules, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, MSN, and Teva Pharms, and is included in twenty-two NDAs. It is available from eighteen suppliers. Additional details are available on the LISDEXAMFETAMINE DIMESYLATE profile page.
The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Nineteen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Nineteen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 218850
| Tradename: | LISDEXAMFETAMINE DIMESYLATE |
| Applicant: | Specgx Llc |
| Ingredient: | lisdexamfetamine dimesylate |
| Patents: | 0 |
Pharmacology for NDA: 218850
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 218850
Suppliers and Packaging for NDA: 218850
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 218850 | ANDA | SpecGx LLC | 0406-5124 | 0406-5124-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5124-01) |
| LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 218850 | ANDA | SpecGx LLC | 0406-5125 | 0406-5125-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5125-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 17, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 17, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 30MG | ||||
| Approval Date: | Dec 17, 2024 | TE: | AB | RLD: | No | ||||
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