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, Aurobindo Pharma Usa, Inventia, Mankind Pharma, Omsav Pharma, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in eleven NDAs. It is available from twenty-nine 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 | ST. MARY'S MEDICAL PARK PHARMACY | 60760-853 | 60760-853-14 | 14 CAPSULE in 1 BOTTLE, PLASTIC (60760-853-14) |
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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