| NDC Code: |
16590-230 |
| Proprietary Name: |
Tramadol Hydrochloride and Acetaminophen |
| Suffix: |
|
| Non-Proprietary Name: |
Tramadol Hydrochloride and Acetaminophen |
| Dosage Form: |
TABLET, COATED |
| Method: |
ORAL |
| Original Marketing Date: |
15-08-2001 |
| Category Name: |
NDA |
| Application Number: |
NDA021123 |
| Labeler: |
STAT RX USA LLC |
| Substance Name: |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
| Active Numerator Strength: |
325; 37.5 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule: |
|
