| NDC Code: |
52125-650 |
| Proprietary Name: |
Nitrofurantoin Monohydrate/ Macrocrystalline |
| Suffix: |
|
| Non-Proprietary Name: |
Nitrofurantoin Monohydrate/Macrocrystalline |
| Dosage Form: |
CAPSULE |
| Method: |
ORAL |
| Original Marketing Date: |
24-06-2013 |
| Category Name: |
NDA |
| Application Number: |
NDA020064 |
| Labeler: |
REMEDYREPACK INC. |
| Substance Name: |
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
| Active Numerator Strength: |
25; 75 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] |
| DEA Schedule: |
|
