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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212319
Company: RAFA LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE (AUTOINJECTOR) ATROPINE EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION;INTRAMUSCULAR Discontinued None 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
07/09/2018 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/212319Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212319s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212319Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212319s002lbl.pdf
07/09/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf
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