TRAMADOL HYDROCHLORIDE - tramadol hydrochloride
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Field |
Value |
NDC Code: |
35356-546 |
Proprietary Name: |
TRAMADOL HYDROCHLORIDE |
Suffix: |
|
Non-Proprietary Name: |
tramadol hydrochloride |
Dosage Form: |
TABLET, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
01-06-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA078783 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
TRAMADOL HYDROCHLORIDE |
Active Numerator Strength: |
100 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
|