Details for New Drug Application (NDA): 021514
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NDA 021514 describes DAYTRANA, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DAYTRANA profile page.
The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
Summary for 021514
| Tradename: | DAYTRANA |
| Applicant: | Noven Pharms Inc |
| Ingredient: | methylphenidate |
| Patents: | 3 |
Pharmacology for NDA: 021514
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 021514
Suppliers and Packaging for NDA: 021514
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514 | NDA AUTHORIZED GENERIC | PADAGIS US LLC | 0574-2410 | 0574-2410-65 | 1 TRAY in 1 CARTON (0574-2410-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 27.5 mg in 1 PATCH |
| DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514 | NDA AUTHORIZED GENERIC | PADAGIS US LLC | 0574-2415 | 0574-2415-65 | 1 TRAY in 1 CARTON (0574-2415-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 41.3 mg in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MG/9HR (1.1MG/HR) | ||||
| Approval Date: | Apr 6, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,632,802 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,034,370 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,668,981 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF | ||||||||
Expired US Patents for NDA 021514
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | 5,958,446 | ⤷ Get Started Free |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | 6,348,211 | ⤷ Get Started Free |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | 9,668,981 | ⤷ Get Started Free |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-004 | Apr 6, 2006 | 9,668,981 | ⤷ Get Started Free |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-001 | Apr 6, 2006 | 5,958,446 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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