Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213561
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL 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
12/01/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ATROPINE SULFATE

SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL; 8MG/20ML (0.4MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROPINE SULFATE ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Prescription No AP 213424 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Prescription Yes AP 209260 FRESENIUS KABI USA
ATROPINE SULFATE ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Prescription No AP 213561 HIKMA

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