Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020698
Company: BRAINTREE

Products on NDA 020698

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020698

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20698pi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20698ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020698.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2004	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698s009ltr.pdf
03/13/2009	SUPPL-7	Efficacy-New Indication		Label is not available on this site.
06/21/2001	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/05/2004	SUPPL-4	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698scp004ltr.pdf
06/20/2001	SUPPL-3	Labeling		Label is not available on this site.
08/18/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/13/2009	SUPPL-1	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 020698

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20698pi.pdf