Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090600
Company: LANNETT CO INC

Products on ANDA 090600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYCOLAX	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION;ORAL	Discontinued	None	No	No
GLYCOLAX	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090600s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090600s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2012	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
10/21/2011	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
03/08/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090600

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090600s000lbl.pdf