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Generated: June 26, 2017

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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 Teva Branded Pharm 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-eight suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for NDA: 021998

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021998

Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization

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 Rebel Distributors Corp 21695-973 21695-973-01 1 BLISTER PACK in 1 CARTON (21695-973-01) > 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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Covington
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Farmers Insurance

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