Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209784
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/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 |
---|---|---|---|---|---|---|---|
08/23/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209784Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/24/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
EPHEDRINE SULFATE
SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AKOVAZ | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208289 | EXELA PHARMA |
CORPHEDRA | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208943 | PAR STERILE PRODUCTS |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215825 | AGGREGA PHARMA, LLC |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208609 | AKORN |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212932 | AMNEAL |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212649 | DR REDDYS LABS LTD |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214579 | EUGIA PHARMA |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209646 | FRESENIUS KABI USA |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216146 | GLAND PHARMA LTD |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214334 | HIKMA |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216129 | MANKIND PHARMA |
EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209784 | SANDOZ INC |
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