Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205005
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
12/12/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2022 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/08/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NITROFURANTOIN
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 |