Details for New Drug Application (NDA): 212607
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The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 212607
Tradename: | NITROFURANTOIN |
Applicant: | Aurobindo Pharma |
Ingredient: | nitrofurantoin |
Patents: | 0 |
Suppliers and Packaging for NDA: 212607
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 212607 | ANDA | Aurobindo Pharma Limited | 59651-206 | 59651-206-23 | 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE |
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 212607 | ANDA | Rising Pharma Holdings, Inc. | 64980-593 | 64980-593-24 | 1 BOTTLE in 1 CARTON (64980-593-24) / 230 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | May 11, 2023 | TE: | AB | RLD: | No |
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