Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208768
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/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 |
---|---|---|---|---|---|---|---|
05/25/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208768Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208768Orig1s000ltr.pdf |
POSACONAZOLE
SOLUTION;INTRAVENOUS; 300MG/16.7ML (18MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NOXAFIL | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 205596 | MERCK SHARP DOHME |
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208768 | ENDO OPERATIONS |
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214842 | EUGIA PHARMA |
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209983 | FRESENIUS KABI USA |
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217553 | GLAND PHARMA LTD |
POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211500 | MYLAN LABS LTD |