Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 212667
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) 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
07/12/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212667Orig1s000ltr.pdf

DAPTOMYCIN

POWDER;IV (INFUSION); 350MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription No AP 212667 ACCORD HLTHCARE
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription Yes AP 208385 SAGENT PHARMS INC

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