Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
07/09/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74967ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2023 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/15/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
11/14/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2011 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/25/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/28/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/03/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/27/1998 | SUPPL-1 | Manufacturing (CMC) |
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 |