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FDA Approval

Plan B

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

April 23, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(0.75 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Plan B

NDC Product Code

54868-4894

Application Number

NDA021045

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

April 23, 2012

Ingredients

LevonorgestrelActive

Code: 5W7SIA7YZWClass: ACTIBQuantity: 0.75 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, POTATOInactive

Code: 8I089SAH3TClass: IACT

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