Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207092
Company: GLAND
Company: GLAND
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | No | No |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;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 |
---|---|---|---|---|---|---|---|
09/29/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207092Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/05/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
09/05/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CASPOFUNGIN ACETATE
POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CANCIDAS | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | AREVA PHARMS |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | HENGRUI PHARMA |
POWDER;INTRAVENOUS; 70MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CANCIDAS | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | AREVA PHARMS |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | HENGRUI PHARMA |