Details for New Drug Application (NDA): 090404
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The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 090404
Tradename: | TRAMADOL HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | tramadol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090404
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 090404
Suppliers and Packaging for NDA: 090404
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 090404 | ANDA | DirectRX | 61919-597 | 61919-597-20 | 20 TABLET, FILM COATED in 1 BOTTLE (61919-597-20) |
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 090404 | ANDA | DirectRX | 61919-597 | 61919-597-30 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-597-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jan 31, 2011 | TE: | AB | RLD: | No |
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