Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018634
Company: ALCON PHARMS LTD
Company: ALCON PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETADINE | POVIDONE-IODINE | 5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 08/26/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18634slr007ltr.pdf |
| 02/07/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |