Details for New Drug Application (NDA): 207372
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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 207372
Tradename: | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
Applicant: | Amneal Pharms |
Ingredient: | nitrofurantoin; nitrofurantoin, macrocrystalline |
Patents: | 0 |
Suppliers and Packaging for NDA: 207372
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 207372 | ANDA | AvPAK | 50268-625 | 50268-625-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15) / 1 CAPSULE in 1 BLISTER PACK (50268-625-11) |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 207372 | ANDA | RPK Pharmaceuticals, Inc. | 53002-7042 | 53002-7042-1 | 6 CAPSULE in 1 BOTTLE (53002-7042-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG;25MG | ||||
Approval Date: | May 15, 2017 | TE: | AB | RLD: | No |
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