Details for New Drug Application (NDA): 202100
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NDA 202100 describes QUILLIVANT XR, which is a drug marketed by Nextwave and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUILLIVANT XR profile page.
The generic ingredient in QUILLIVANT XR 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.
The generic ingredient in QUILLIVANT XR 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 202100
| Tradename: | QUILLIVANT XR |
| Applicant: | Nextwave |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 7 |
Pharmacology for NDA: 202100
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 202100
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NDA | NextWave Pharmaceuticals, Inc | 24478-321 | 24478-321-02 | 1 BOTTLE in 1 CARTON (24478-321-02) / 60 mL in 1 BOTTLE |
| QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NDA | NextWave Pharmaceuticals, Inc | 24478-322 | 24478-322-04 | 1 BOTTLE in 1 CARTON (24478-322-04) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 5MG/ML | ||||
| Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 15, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 15, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2 | ||||||||
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