Details for New Drug Application (NDA): 200533
✉ Email this page to a colleague
NDA 200533 describes NUCYNTA ER, which is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NUCYNTA ER profile page.
The generic ingredient in NUCYNTA ER is tapentadol hydrochloride. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
The generic ingredient in NUCYNTA ER is tapentadol hydrochloride. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 200533
| Tradename: | NUCYNTA ER |
| Applicant: | Collegium Pharm Inc |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 200533
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 200533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | NDA AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-0936 | 0054-0936-21 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0936-21) |
| NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | NDA AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-0937 | 0054-0937-21 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0937-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Aug 25, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 22, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 25, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 200533
Complete Access Available with Subscription
