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Application 211911
- Type
- NDA
- Sponsor
- ALLERGAN INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DURYSTA | BIMATOPROST | IMPLANT;OPHTHALMIC | 10MCG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
| 0023-9652 | DURYSTA | bimatoprost | Allergan, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79868 | SUPPL | 2024-10-11 |
| 79860 | SUPPL | 2024-10-11 |
| 65152 | SUPPL | 2020-11-04 |
| 65148 | SUPPL | 2020-11-04 |
| 64438 | ORIG | 2020-08-27 |
| 62042 | ORIG | 2020-03-05 |
| 62038 | ORIG | 2020-03-05 |