| NDC Code: |
65162-617 |
| Proprietary Name: |
Tramadol Hydrochloride and Acetaminophen |
| Suffix: |
|
| Non-Proprietary Name: |
Tramadol Hydrochloride and Acetaminophen |
| Dosage Form: |
TABLET |
| Method: |
ORAL |
| Original Marketing Date: |
17-12-2009 |
| Category Name: |
ANDA |
| Application Number: |
ANDA090485 |
| Labeler: |
AMNEAL PHARMACEUTICALS |
| 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: |
|
