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FDA Approval

PostDay One-Step

CompanyHome Health Brands, LLC (DUNS: 119462541)

Effective Date

April 23, 2025

Labeling Type

HUMAN OTC DRUG LABEL

Active Ingredients

Levonorgestrel(1.5 mg in 1 1)

Products (1)

PostDay One-Step

NDC Product Code

85506-100

Application Number

ANDA207044

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 23, 2025

Ingredients

LevonorgestrelActive

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

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

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