NUCYNTA - tapentadol hydrochloride
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Field |
Value |
NDC Code: |
35356-810 |
Proprietary Name: |
NUCYNTA |
Suffix: |
ER |
Non-Proprietary Name: |
tapentadol hydrochloride |
Dosage Form: |
TABLET, FILM COATED, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
25-08-2011 |
Category Name: |
NDA |
Application Number: |
NDA200533 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
TAPENTADOL HYDROCHLORIDE |
Active Numerator Strength: |
50 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule: |
CII |