Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201355
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/14/2013 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/201355Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/28/2016 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/25/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NITROFURANTOIN
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 |