Application 021744
- Type
- NDA
- Sponsor
- DEPOMED INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROQUIN XR | CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13913-001 | Proquin | ciprofloxacin hydrochloride | Depomed, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 52755 | ORIG | 2018-02-28 |
| 16296 | SUPPL | 2011-03-04 |
| 6106 | SUPPL | 2011-03-03 |
| 24007 | ORIG | 2011-01-13 |
| 16295 | SUPPL | 2011-01-04 |
| 6105 | SUPPL | 2011-01-04 |
| 28508 | SUPPL | 2009-05-13 |
| 37572 | SUPPL | 2009-05-11 |
| 6104 | SUPPL | 2008-10-23 |
| 6103 | SUPPL | 2008-10-23 |
| 37571 | SUPPL | 2008-10-09 |
| 28507 | SUPPL | 2008-10-08 |
| 42295 | ORIG | 2007-09-11 |
| 37570 | SUPPL | 2007-09-06 |
| 28506 | SUPPL | 2007-09-06 |
| 16294 | SUPPL | 2007-08-14 |
| 16293 | SUPPL | 2007-08-02 |
| 6102 | SUPPL | 2007-08-02 |
| 28505 | SUPPL | 2006-08-21 |
| 37569 | SUPPL | 2006-08-18 |
| 37568 | ORIG | 2005-05-20 |
| 6101 | ORIG | 2005-05-20 |