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Application 016968
- Type
- NDA
- Sponsor
- ALCON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIOSTAT | CARBACHOL | SOLUTION;INTRAOCULAR | 0.01% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0065-0023 | MIOSTAT | carbachol | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0023 | MIOSTAT | carbachol | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0023 | MIOSTAT | carbachol | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0023 | MIOSTAT | carbachol | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0023 | MIOSTAT | carbachol | Alcon Laboratories, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10945 | SUPPL | 2016-01-26 |
| 13063 | SUPPL | 2016-01-22 |
| 33211 | SUPPL | 2004-11-16 |
| 521 | SUPPL | 2004-11-16 |
| 10944 | SUPPL | 2002-11-25 |
| 520 | SUPPL | 2002-11-25 |