Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206561
Company: NAVINTA LLC
Company: NAVINTA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDOMETHACIN SODIUM | INDOMETHACIN SODIUM | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/19/2017 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206561Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206561Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/07/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/19/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206561Orig1s000lbl.pdf |
INDOMETHACIN SODIUM
INJECTABLE;INJECTION; EQ 1MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN SODIUM | INDOMETHACIN SODIUM | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204118 | HOSPIRA |
INDOMETHACIN SODIUM | INDOMETHACIN SODIUM | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206561 | NAVINTA LLC |
INDOMETHACIN SODIUM | INDOMETHACIN SODIUM | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078713 | WEST-WARD PHARMS INT |