Details for New Drug Application (NDA): 020281
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The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-two 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: | 0 |
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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 3, 1995 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 3, 1995 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020281
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-002 | Mar 3, 1995 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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