Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209784
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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