Details for New Drug Application (NDA): 208708
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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 208708
Tradename: | TRAMADOL HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | tramadol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208708
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 208708
Suppliers and Packaging for NDA: 208708
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 208708 | ANDA | Medsource Pharmaceuticals | 45865-261 | 45865-261-30 | 30 TABLET, COATED in 1 BOTTLE (45865-261-30) |
TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 208708 | ANDA | Medsource Pharmaceuticals | 45865-261 | 45865-261-60 | 60 TABLET, COATED in 1 BOTTLE (45865-261-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 28, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 28, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 27, 2023 | TE: | RLD: | No |
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