Details for New Drug Application (NDA): 073652
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The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 073652
Tradename: | NITROFURANTOIN |
Applicant: | Impax Labs Inc |
Ingredient: | nitrofurantoin, macrocrystalline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 073652
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 073652 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1645 | 0115-1645-01 | 100 CAPSULE in 1 BOTTLE (0115-1645-01) |
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 073652 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1645 | 0115-1645-03 | 1000 CAPSULE in 1 BOTTLE (0115-1645-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 28, 1993 | TE: | AB | RLD: | No |
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