Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210997
Company: EXELA PHARMA

Products on NDA 210997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYRX-PF	GLYCOPYRROLATE	0.2MG/ML (0.2MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	Yes	Yes
GLYRX-PF	GLYCOPYRROLATE	0.4MG/2ML (0.2MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	Yes	Yes
GLYRX-PF	GLYCOPYRROLATE	1MG/5ML (0.2MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	Yes	Yes
GLYRX-PF	GLYCOPYRROLATE	0.6MG/3ML (0.2MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2018	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210997Orig1s000,210997Orig2s000TOC.cfm
07/11/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210997Orig1s000,210997Orig2s000TOC.cfm

Labels for NDA 210997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2018	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf
07/11/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf