Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074336
Company: ATHEM
Company: ATHEM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/1995 | 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 |
|---|---|---|---|---|---|
| 04/08/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/19/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/12/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/16/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/21/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 12/13/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |