Hydromorphone Hydrochloride - hydromorphone hydrochloride
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Field |
Value |
NDC Code: |
0054-0386 |
Proprietary Name: |
Hydromorphone Hydrochloride |
Suffix: |
|
Non-Proprietary Name: |
hydromorphone hydrochloride |
Dosage Form: |
SOLUTION |
Method: |
ORAL |
Original Marketing Date: |
01-03-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA074653 |
Labeler: |
ROXANE LABORATORIES, INC |
Substance Name: |
HYDROMORPHONE HYDROCHLORIDE |
Active Numerator Strength: |
1 |
Active Ingredient Unit: |
mg/mL |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CII |