Details for New Drug Application (NDA): 208516
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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-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 208516
Tradename: | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
Applicant: | Sunny |
Ingredient: | nitrofurantoin; nitrofurantoin, macrocrystalline |
Patents: | 0 |
Suppliers and Packaging for NDA: 208516
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 208516 | ANDA | Trigen Laboratories, LLC | 13811-719 | 13811-719-10 | 100 CAPSULE in 1 BOTTLE (13811-719-10) |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 208516 | ANDA | RPK Pharmaceuticals, Inc. | 53002-7043 | 53002-7043-1 | 6 CAPSULE in 1 BOTTLE (53002-7043-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG;25MG | ||||
Approval Date: | May 24, 2018 | TE: | AB | RLD: | No |
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