Details for New Drug Application (NDA): 208516
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NDA 208516 describes NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), which is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in eleven NDAs. It is available from thirty suppliers. Additional details are available on the NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) profile page.
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.
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 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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