Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205375
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
11/06/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLOFARABINE
SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212034 | ACCORD HLTHCARE |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208857 | AMNEAL |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205375 | DR REDDYS |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207831 | GLAND PHARMA LTD |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213461 | MEITHEAL |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209775 | MSN |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208860 | MYLAN LABS LTD |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216233 | SCINOPHARM TAIWAN |
CLOLAR | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021673 | GENZYME |