Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208516
Company: SUNNY
Company: SUNNY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/24/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
CAPSULE;ORAL; 75MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MACROBID | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | Yes | AB | 020064 | ALMATICA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 207372 | AMNEAL PHARMS |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 209225 | AUROBINDO PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 211013 | INVENTIA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 217357 | MANKIND PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 217073 | OMSAV PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 077066 | SANDOZ |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 208516 | SUNNY |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 202250 | WATSON LABS INC |