Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200563
Company: CHARTWELL
Company: CHARTWELL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPROFLOXACIN | CIPROFLOXACIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
CIPROFLOXACIN | CIPROFLOXACIN | 500MG/5ML | FOR SUSPENSION;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/05/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200563Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/14/2015 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
02/06/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CIPROFLOXACIN
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CIPRO | CIPROFLOXACIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020780 | BAYER HLTHCARE |
CIPROFLOXACIN | CIPROFLOXACIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 200563 | CHARTWELL |
FOR SUSPENSION;ORAL; 500MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CIPRO | CIPROFLOXACIN | 500MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020780 | BAYER HLTHCARE |
CIPROFLOXACIN | CIPROFLOXACIN | 500MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 200563 | CHARTWELL |