Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009175
Company: CASPER PHARMA LLC
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FURADANTIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | AB | Yes | No |
| FURADANTIN | NITROFURANTOIN | 50MG/5ML | SUSPENSION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/1953 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 02/01/2024 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009175Orig1s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/009175Orig1s050ltr.pdf | |
| 06/09/2023 | SUPPL-49 | Manufacturing (CMC)-New Strength |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009175Orig1s0049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009175Orig1s049ltr.pdf | |
| 12/23/2020 | SUPPL-48 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009175Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009175Orig1s048ltr.pdf | ||
| 06/11/2019 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009175s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/009175Orig1s046ltr.pdf | |
| 07/11/2016 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2010 | SUPPL-39 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s039ltr.pdf |
| 10/27/2010 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s038ltr.pdf | |
| 02/06/2009 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009175s037ltr.pdf | |
| 11/04/2013 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009175Orig1s036ltr.pdf |
| 05/30/2008 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009175s033ltr.pdf |
| 08/25/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/27/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/13/1988 | SUPPL-19 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm |
| 06/12/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/12/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/17/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/25/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/03/1978 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1973 | SUPPL-6 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/01/2024 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009175Orig1s050lbl.pdf | |
| 06/09/2023 | SUPPL-49 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009175Orig1s0049lbl.pdf | |
| 12/23/2020 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009175Orig1s048lbl.pdf | |
| 06/11/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009175s046lbl.pdf | |
| 11/04/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf |
| 10/27/2010 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf | |
| 02/06/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf |
FURADANTIN
SUSPENSION;ORAL; 25MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FURADANTIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 009175 | CASPER PHARMA LLC |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 205180 | ACTAVIS MID ATLANTIC |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 201679 | AMNEAL PHARMS |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212607 | AUROBINDO PHARMA |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 201355 | NOSTRUM LABS INC |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 201693 | NOVEL LABS INC |
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 216385 | NOVITIUM PHARMA |