DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 091498
The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 091498
Tradename: | TRAMADOL HYDROCHLORIDE |
Applicant: | Cspc Ouyi Pharm Co |
Ingredient: | tramadol hydrochloride |
Patents: | 0 |
Therapeutic Class: | Analgesics |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091498
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 091498
Suppliers and Packaging for NDA: 091498
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 091498 | ANDA | Medsource Pharmaceuticals | 45865-357 | N | 45865-357-20 |
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 091498 | ANDA | Medsource Pharmaceuticals | 45865-357 | N | 45865-357-60 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 29, 2013 | TE: | AB | RLD: | No |
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