Approval · Notice of Compliance 8715 · 2007

PLAN B: Notice of Compliance 8715

Issued April 17, 2007

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number: 8715
Date: April 17, 2007
Company: Duramed Pharmaceuticals, Inc., A Subsidiary Of Barr Pharmaceuticals, Inc.
Product type: Nonprescription Pharmaceutical
Submission: Supplement to a New Drug Submission (SNDS), supplement
Submission class: Other
Reason: New dosing regimen: two tablets of plan b (levonorgestrel 0.75mg) to be taken together, orally, as soon as possible but within 72 hours after unprotected intercourse
Therapeutic class: Emergency contraception

Products in this notice

Brand	DIN	Status today
PLAN B	Not yet assigned	—

Medicinal ingredients

LEVONORGESTREL 0.75 MG per TAB