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Details for New Drug Application (NDA): 020281
NDA 020281 describes ULTRAM, which is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the ULTRAM profile page.
The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 020281
| Tradename: | ULTRAM |
| Applicant: | Janssen Pharms |
| Ingredient: | tramadol hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020281
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 020281
Suppliers and Packaging for NDA: 020281
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281 | NDA | Janssen Pharmaceuticals, Inc. | 50458-659 | 50458-659-60 | 100 TABLET, COATED in 1 BOTTLE (50458-659-60) |
Paragraph IV (Patent) Challenges for 020281
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ULTRAM | TABLET;ORAL | tramadol hydrochloride | 020281 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 3, 1995 | TE: | RLD: | No | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 12, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 3, 1995 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Apr 12, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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