Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076722
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 60MG/2ML | INJECTABLE; INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/27/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076722_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |