Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020064
Company: ALMATICA
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 |
| 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 |