Details for New Drug Application (NDA): 209225
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The generic ingredient in NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 209225
Tradename: | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
Applicant: | Aurobindo Pharma |
Ingredient: | nitrofurantoin; nitrofurantoin, macrocrystalline |
Patents: | 0 |
Suppliers and Packaging for NDA: 209225
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 209225 | ANDA | Aurobindo Pharma Limited | 65862-929 | 65862-929-01 | 100 CAPSULE in 1 BOTTLE (65862-929-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG;25MG | ||||
Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No |
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