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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 021998

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NDA 021998 describes PLAN B ONE-STEP, which is a drug marketed by Fdn Consumer and is included in one NDA. It is available from three suppliers. Additional details are available on the PLAN B ONE-STEP profile page.

The generic ingredient in PLAN B ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 021998
Applicant:Fdn Consumer
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021998
Suppliers and Packaging for NDA: 021998
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLAN B ONE-STEP levonorgestrel TABLET;ORAL 021998 NDA A-S Medication Solutions 50090-3830 50090-3830-0 1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3830-0) > 1 TABLET in 1 BLISTER PACK
PLAN B ONE-STEP levonorgestrel TABLET;ORAL 021998 NDA AUTHORIZED GENERIC Teva Women's Health, Inc. 51285-100 51285-100-88 1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-100-88) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Jul 10, 2009TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

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