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Application 017760
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FML | FLUOROMETHOLONE | OINTMENT;OPHTHALMIC | 0.1% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0023-0316 | FML | fluorometholone | Allergan, Inc. | NDA | Current |
| 0023-0316 | FML | fluorometholone | Allergan, Inc. | NDA | Current |
| 0023-0316 | FML | fluorometholone | Allergan, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 11057 | SUPPL | 2013-02-14 |
| 13893 | SUPPL | 2013-02-13 |
| 697 | SUPPL | 2007-09-25 |
| 11056 | SUPPL | 2003-06-16 |
| 696 | SUPPL | 2001-07-13 |