Nitrofurantoin Monohydrate/Macrocrystals - Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline
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Field |
Value |
NDC Code: |
0378-3422 |
Proprietary Name: |
Nitrofurantoin Monohydrate/Macrocrystals |
Suffix: |
|
Non-Proprietary Name: |
Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline |
Dosage Form: |
CAPSULE |
Method: |
ORAL |
Original Marketing Date: |
14-09-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA076648 |
Labeler: |
MYLAN PHARMACEUTICALS 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: |
|