Details for New Drug Application (NDA): 209311
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NDA 209311 describes JORNAY PM, which is a drug marketed by Ironshore Pharms and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the JORNAY PM profile page.
The generic ingredient in JORNAY PM 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 JORNAY PM 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 209311
| Tradename: | JORNAY PM |
| Applicant: | Ironshore Pharms |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 15 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209311
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 209311
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JORNAY PM | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 209311 | NDA | Ironshore Pharmaceuticals Inc. | 71376-201 | 71376-201-03 | 100 CAPSULE in 1 BOTTLE (71376-201-03) |
| JORNAY PM | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 209311 | NDA | Ironshore Pharmaceuticals Inc. | 71376-202 | 71376-202-03 | 100 CAPSULE in 1 BOTTLE (71376-202-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 8, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 23, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 23, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 23, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
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