Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211880
Company: INTL MEDICATION SYS
Company: INTL MEDICATION SYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPINEPHRINE | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
04/24/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211880Orig1s000ltr.pdf |
EPINEPHRINE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADRENALIN | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 204640 | ENDO OPERATIONS |
EPINEPHRINE | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 217192 | AM REGENT |
EPINEPHRINE | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 211880 | INTL MEDICATION SYS |