FDA Approval for VASOPRESSIN issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 211857
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASOPRESSIN | VASOPRESSIN | 20UNITS/ML (20UNITS/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 |
|---|---|---|---|---|---|---|---|
| 07/18/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211857Orig1s000TA_ltr.pdf |
VASOPRESSIN
SOLUTION;INTRAVENOUS; 20UNITS/ML (20UNITS/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VASOPRESSIN | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211857 | AMPHASTAR PHARMS INC |
| VASOPRESSIN | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211538 | EAGLE PHARMS |
| VASOSTRICT | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204485 | PAR STERILE PRODUCTS |