Details for New Drug Application (NDA): 077025
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The generic ingredient in NITROFURANTOIN 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 077025
Tradename: | NITROFURANTOIN |
Applicant: | Aurobindo Pharma Usa |
Ingredient: | nitrofurantoin, macrocrystalline |
Patents: | 0 |
Suppliers and Packaging for NDA: 077025
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 077025 | ANDA | A-S Medication Solutions | 50090-7308 | 50090-7308-0 | 28 CAPSULE in 1 BOTTLE (50090-7308-0) |
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 077025 | ANDA | A-S Medication Solutions | 50090-7308 | 50090-7308-2 | 20 CAPSULE in 1 BOTTLE (50090-7308-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 18, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Oct 2, 2024 | TE: | AB | RLD: | No |
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