Imipenem and Cilastatin - Imipenem and Cilastatin Sodium
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Field |
Value |
NDC Code: |
63323-322 |
Proprietary Name: |
Imipenem and Cilastatin |
Suffix: |
|
Non-Proprietary Name: |
Imipenem and Cilastatin Sodium |
Dosage Form: |
INJECTION, POWDER, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
03-01-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA090577 |
Labeler: |
APP PHARMACEUTICALS, LLC |
Substance Name: |
CILASTATIN SODIUM; IMIPENEM |
Active Numerator Strength: |
500; 500 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] |
DEA Schedule: |
|