Application 205548
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | SUSPENSION/DROPS;OTIC | 0.3%;0.1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-628 | Ciprofloxacin and Dexamethasone | Ciprofloxacin and Dexamethasone | NorthStar RxLLC | ANDA | Current |
| 16714-628 | Ciprofloxacin and Dexamethasone | Ciprofloxacin and Dexamethasone | NorthStar RxLLC | ANDA | Current |
| 43598-326 | Ciprofloxacin and Dexamethasone | Ciprofloxacin and Dexamethasone | Dr. Reddy's Laboratories, Inc. | ANDA | Current |
| 43598-326 | Ciprofloxacin and Dexamethasone | Ciprofloxacin and Dexamethasone | Dr. Reddy's Laboratories, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64606 | ORIG | 2020-09-18 |