Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205548
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/10/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205548Orig1s000ltr.pdf |
CIPROFLOXACIN AND DEXAMETHASONE
SUSPENSION/DROPS;OTIC; 0.3%;0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CIPRODEX | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | Yes | AB | 021537 | SANDOZ |
CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | No | AB | 205548 | DR REDDYS |
CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | No | AB | 215768 | SENTISS |
CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | No | AB | 210470 | SUN PHARM |
CIPROFLOXACIN; DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | No | AB | 216501 | AMNEAL |