Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213806
Company: AVET LIFESCIENCES
Company: AVET LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/07/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PENTAMIDINE ISETHIONATE
INJECTABLE;INJECTION; 300MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PENTAM | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 019264 | FRESENIUS KABI USA |
PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 213806 | AVET LIFESCIENCES |
PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206666 | SETON PHARMS |
PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206982 | XGEN PHARMS |