Application 075817
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE | No | No |
| 003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 500MG BASE | No | No |
| 004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 750MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7098 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 10544-605 | Ciprofloxacin | ciprofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 11819-363 | Ciprofloxacin | ciprofloxacin | HHS/Program Support Center/Supply Service Center | ANDA | Current |
| 51079-182 | Ciprofloxacin | ciprofloxacin | Mylan Institutional Inc. | ANDA | Current |
| 55154-5376 | Ciprofloxacin | ciprofloxacin | Cardinal Health | ANDA | Current |
| 68645-060 | Ciprofloxacin | ciprofloxacin | Legacy Pharmaceutical Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8796 | ORIG | 2004-06-24 |