Drugs@FDA: FDA-Approved Drugs
Company: ALMATICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MACROBID | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/24/1991 | 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 |
---|---|---|---|---|---|
03/02/2023 | SUPPL-33 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020064Orig1s033ltr.pdf |
01/21/2021 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020064Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020064Orig1s029ltr.pdf | |
01/07/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/06/2013 | SUPPL-21 | 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/2013/020064s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020064Orig1s021ltr.pdf |
06/06/2011 | SUPPL-20 | Labeling-Package Insert |
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-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020064s019ltr.pdf | |
06/27/2007 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020064s017ltr.pdf |
10/30/2003 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr014ltr.pdf | |
02/04/2003 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr013ltr.pdf |
11/03/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/17/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/16/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/27/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
02/13/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/17/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/23/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/09/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/20/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/24/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/21/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020064Orig1s029lbl.pdf | |
01/21/2021 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020064Orig1s029lbl.pdf | |
09/06/2013 | SUPPL-21 | 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/2013/020064s021lbl.pdf |
03/05/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf | |
10/30/2003 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf |
MACROBID
CAPSULE;ORAL; 75MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MACROBID | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | Yes | AB | 020064 | ALMATICA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 207372 | AMNEAL PHARMS |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 209225 | AUROBINDO PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 211013 | INVENTIA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 217357 | MANKIND PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 217073 | OMSAV PHARMA |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 077066 | SANDOZ |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 208516 | SUNNY |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Prescription | No | AB | 202250 | WATSON LABS INC |