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FDA Approval

Plan B One-Step

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

September 13, 2011

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(1.5 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (1)

Plan B One-Step

NDC Product Code

21695-973

Application Number

NDA021998

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 14, 2009

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, POTATOInactive

Code: 8I089SAH3TClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LevonorgestrelActive

Code: 5W7SIA7YZWClass: ACTIBQuantity: 1.5 mg in 1 1

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