Application 084109
- Type
- ANDA
- Sponsor
- ALCON LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride | Alcon Laboratories, Inc. | ANDA | Current |