Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012827
Company: CASPER PHARMA LLC

Products on NDA 12827

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROBINUL	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	AA	Yes	No
ROBINUL FORTE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	AA	Yes	No

Labels for NDA 012827

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2022	SUPPL-59	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012827s059lbl.pdf
07/16/1985	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/012827s034lbl.pdf