Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212007
Company: EXELA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINC CHLORIDE ZINC CHLORIDE EQ 1MG ZINC/ML INJECTABLE;INJECTION 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
05/21/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212007Orig1s000ltr.pdf

ZINC CHLORIDE

INJECTABLE;INJECTION; EQ 1MG ZINC/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZINC CHLORIDE ZINC CHLORIDE EQ 1MG ZINC/ML INJECTABLE;INJECTION Prescription No AP 212007 EXELA PHARMA
ZINC CHLORIDE IN PLASTIC CONTAINER ZINC CHLORIDE EQ 1MG ZINC/ML INJECTABLE;INJECTION Prescription Yes AP 018959 HOSPIRA

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