Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073652
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 01/28/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2015 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/12/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/16/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 04/17/2015 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/12/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/21/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NITROFURANTOIN
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 |