Details for New Drug Application (NDA): 075964
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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 075964
Tradename: | TRAMADOL HYDROCHLORIDE |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | tramadol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 075964
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 075964
Suppliers and Packaging for NDA: 075964
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 075964 | ANDA | Major Pharmaceuticals | 0904-7179 | 0904-7179-61 | 100 BLISTER PACK in 1 CARTON (0904-7179-61) / 1 TABLET in 1 BLISTER PACK |
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 075964 | ANDA | Medsource Pharmaceuticals | 45865-115 | 45865-115-21 | 21 TABLET in 1 BOTTLE (45865-115-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 19, 2002 | TE: | AB | RLD: | No |
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