Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201722
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | AB | No | No |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | 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 |
---|---|---|---|---|---|---|---|
02/16/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
NITROFURANTOIN
CAPSULE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 016620 | ALMATICA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211935 | ALEMBIC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217272 | MANKIND PHARMA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 201722 | SUN PHARM INDUSTRIES |
CAPSULE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 016620 | ALMATICA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211935 | ALEMBIC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 074967 | AUROBINDO PHARMA USA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 073671 | IMPAX LABS INC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 217272 | MANKIND PHARMA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 203233 | NOVEL LABS INC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 201722 | SUN PHARM INDUSTRIES |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 205005 | ZYDUS PHARMS |
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 016620 | ALMATICA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211935 | ALEMBIC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 074967 | AUROBINDO PHARMA USA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077025 | AUROBINDO PHARMA USA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 073652 | IMPAX LABS INC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 217272 | MANKIND PHARMA |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203233 | NOVEL LABS INC |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 201722 | SUN PHARM INDUSTRIES |
NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205005 | ZYDUS PHARMS |