Details for New Drug Application (NDA): 217068
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NDA 217068 describes LISDEXAMFETAMINE DIMESYLATE, which is a drug marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, 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 eighteen NDAs. It is available from sixteen suppliers. Additional details are available on the LISDEXAMFETAMINE DIMESYLATE profile page.
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.
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 217068
| Tradename: | LISDEXAMFETAMINE DIMESYLATE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | lisdexamfetamine dimesylate |
| Patents: | 0 |
Pharmacology for NDA: 217068
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 217068
Suppliers and Packaging for NDA: 217068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 217068 | ANDA | Camber Pharmaceuticals, Inc. | 31722-321 | 31722-321-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (31722-321-01) |
| LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 217068 | ANDA | Camber Pharmaceuticals, Inc. | 31722-322 | 31722-322-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (31722-322-01) |
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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