Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215422
Company: STRIDES PHARMA INTL

Products on NDA 215422

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYVISPAH	BACLOFEN	5MG/PACKET	GRANULE;ORAL	Discontinued	None	Yes	No
LYVISPAH	BACLOFEN	10MG/PACKET	GRANULE;ORAL	Discontinued	None	Yes	No
LYVISPAH	BACLOFEN	20MG/PACKET	GRANULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215422lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215422Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215422Orig1s000TOC.html

Labels for NDA 215422

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215422lbl.pdf