Details for New Drug Application (NDA): 211935
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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 211935
Tradename: | NITROFURANTOIN |
Applicant: | Alembic |
Ingredient: | nitrofurantoin, macrocrystalline |
Patents: | 0 |
Suppliers and Packaging for NDA: 211935
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 211935 | ANDA | Alembic Pharmaceuticals Limited | 46708-389 | 46708-389-31 | 100 CAPSULE in 1 BOTTLE (46708-389-31) |
NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 211935 | ANDA | Alembic Pharmaceuticals Limited | 46708-389 | 46708-389-91 | 1000 CAPSULE in 1 BOTTLE (46708-389-91) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 25, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 25, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 25, 2021 | TE: | AB | RLD: | No |
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