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FDA Approval

Levonorgestrel

CompanyNovel Laboratories, Inc. (DUNS: 793518643)

Effective Date

September 15, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(1.5 mg in 1 1)

Registrants (1)

Novel Laboratories, Inc.

DUNS Number

793518643

Manufacturing Establishments (1)

Novel Laboratories, Inc.

Labeler

Novel Laboratories, Inc.

Registrant

Novel Laboratories, Inc.

DUNS Number

793518643

Products (1)

Levonorgestrel

NDC Product Code

40032-622

Application Number

ANDA202508

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 15, 2017

Ingredients

LevonorgestrelActive

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

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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