Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019638
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARDUAN | PIPECURONIUM BROMIDE | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 06/26/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/22/2010 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019638s005ltr.pdf |
| 05/05/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/24/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |