Details for New Drug Application (NDA): 216385
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NDA 216385 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Inventia, Micro Labs, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in thirty-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the NITROFURANTOIN profile page.
The generic ingredient in NITROFURANTOIN 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 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 216385
| Tradename: | NITROFURANTOIN |
| Applicant: | Novitium Pharma |
| Ingredient: | nitrofurantoin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 216385 | ANDA | ANI Pharmaceuticals, Inc. | 70954-496 | 70954-496-10 | 230 mL in 1 BOTTLE (70954-496-10) |
| NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 216385 | ANDA | NorthStar Rx LLC | 72603-176 | 72603-176-01 | 1 BOTTLE in 1 CARTON (72603-176-01) / 230 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Apr 14, 2023 | TE: | AB | RLD: | No | ||||
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