Application 078183
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 212.6MG;EQ 287.5MG BASE | No | No |
| 002 | CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 425.2MG;EQ 574.9MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1743 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1743 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1745 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1745 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31342 | ORIG | 2007-03-31 |