Details for New Drug Application (NDA): 076003
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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 076003
Tradename: | TRAMADOL HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | tramadol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076003
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 076003
Suppliers and Packaging for NDA: 076003
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 076003 | ANDA | RPK Pharmaceuticals, Inc. | 53002-4320 | 53002-4320-1 | 10 TABLET, COATED in 1 BOTTLE (53002-4320-1) |
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 076003 | ANDA | RPK Pharmaceuticals, Inc. | 53002-4320 | 53002-4320-2 | 20 TABLET, COATED in 1 BOTTLE (53002-4320-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 20, 2002 | TE: | AB | RLD: | No |
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