Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077702
Company: AUROBINDO
Company: AUROBINDO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEVIRAPINE | NEVIRAPINE | 50MG/5ML | SUSPENSION;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
05/22/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077702TA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2022 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/21/2019 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/21/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/16/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
NEVIRAPINE
SUSPENSION;ORAL; 50MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEVIRAPINE | NEVIRAPINE | 50MG/5ML | SUSPENSION;ORAL | Prescription | No | AA | 077702 | AUROBINDO |
NEVIRAPINE | NEVIRAPINE | 50MG/5ML | SUSPENSION;ORAL | Prescription | No | AA | 207684 | CIPLA |