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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212319
Company: RAFA LABS LTD

Products on NDA 212319

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212319

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
02/27/2023	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212319Orig1s007ltr.pdf
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

Labels for NDA 212319

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2023	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf
02/27/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf
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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