Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016620
Company: ALMATICA
Company: ALMATICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/1970 | 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 |
|---|---|---|---|---|---|
| 01/21/2021 | SUPPL-76 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016620Orig1s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016620Orig1s076ltr.pdf | |
| 10/15/2015 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2015 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-72 | 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/2013/016620s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016620Orig1s072ltr.pdf |
| 06/06/2011 | SUPPL-70 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf |
| 03/05/2009 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016620s068ltr.pdf | |
| 09/14/2007 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016620s067ltr.pdf | |
| 03/29/2004 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16620slr065ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016620_S065_MACRODANTIN.pdf | |
| 02/04/2003 | SUPPL-64 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16620slr064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016620_S064_MACRODANTIN.pdf |
| 10/21/1998 | SUPPL-63 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016620_S063_MACRODANTIN.pdf |
| 07/16/1997 | SUPPL-62 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016620_S062_MACRODANTIN.pdf |
| 03/27/1997 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 07/30/1996 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-59 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S059_MACRODANTIN.pdf |
| 02/17/1998 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-57 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S057_MACRODANTIN.pdf |
| 02/17/1998 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 12/08/1992 | SUPPL-55 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S055_MACRODANTIN.pdf |
| 12/08/1992 | SUPPL-54 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S054_MACRODANTIN.pdf |
| 12/08/1992 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S053_MACRODANTIN.pdf |
| 12/08/1992 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1990 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1989 | SUPPL-47 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16620_S047_MacrodantinTOC.cfm |
| 05/13/1988 | SUPPL-45 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm |
| 05/19/1993 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1983 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/1980 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/15/1982 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/20/1980 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/16/1979 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/26/1979 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/13/1977 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S020_Macrodantin Capsules.pdf |
| 11/22/1976 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S019_Macrodantin Capsules.pdf |
| 07/21/1976 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S018_Macodantin.pdf |
| 07/21/1976 | SUPPL-17 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S017_Macrodantin Capsules.pdf |
| 07/15/1976 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S016_Macrodantin Capsules.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/21/2021 | SUPPL-76 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016620Orig1s076lbl.pdf | |
| 01/21/2021 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016620Orig1s076lbl.pdf | |
| 09/06/2013 | SUPPL-72 | 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/2013/016620s072lbl.pdf |
| 03/05/2009 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf | |
| 09/14/2007 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf | |
| 03/29/2004 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf |
MACRODANTIN
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 |
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MACRODANTIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 016620 | ALMATICA |
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211935 | ALEMBIC |
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217272 | MANKIND PHARMA |
| NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 201722 | SUN PHARM INDUSTRIES |