Application 018634
- Type
- NDA
- Sponsor
- ALCON PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETADINE | POVIDONE-IODINE | SOLUTION/DROPS;OPHTHALMIC | 5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0411 | Betadine | povidone-iodine | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0411 | Betadine | povidone-iodine | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0411 | Betadine | povidone-iodine | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0411 | Betadine | povidone-iodine | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0411 | Betadine | povidone-iodine | Alcon Laboratories, Inc. | NDA | Current |
| 42254-006 | Betadine | povidone-iodine | Rebel Distributors Corp | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 978 | SUPPL | 2003-06-08 |