Details for New Drug Application (NDA): 201679
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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 201679
Tradename: | NITROFURANTOIN |
Applicant: | Amneal Pharms |
Ingredient: | nitrofurantoin |
Patents: | 0 |
Suppliers and Packaging for NDA: 201679
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 201679 | ANDA | Amneal Pharmaceuticals LLC | 65162-689 | 65162-689-88 | 230 mL in 1 BOTTLE, GLASS (65162-689-88) |
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 201679 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2512 | 69238-2512-9 | 1 BOTTLE, GLASS in 1 CARTON (69238-2512-9) / 230 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | May 11, 2011 | TE: | AB | RLD: | No |
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