Details for New Drug Application (NDA): 201355
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The generic ingredient in NITROFURANTOIN 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 201355
Tradename: | NITROFURANTOIN |
Applicant: | Nostrum Labs Inc |
Ingredient: | nitrofurantoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201355
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 201355 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1996 | 0121-1996-95 | 10 CUP, UNIT-DOSE in 1 CASE (0121-1996-95) / 10 mL in 1 CUP, UNIT-DOSE (0121-1996-10) |
NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 201355 | ANDA | Nostrum Laboratories, Inc. | 29033-515 | 29033-515-32 | 240 mL in 1 BOTTLE, PLASTIC (29033-515-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | Aug 14, 2013 | TE: | AB | RLD: | No |
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