Reference Listed Drug Labeling and Efficacy Supplements Approved in May 2002

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Approval Date

Product Name

Active Ingredient(s)

Dosage Form

NDA No

Supp No

May 2

ACCUTANE

letter

label

isotretinoin

capsule

18-662

SE8 043

Efficacy claim: To provide for additional safety and efficacy information in pediatric labeling for the treatment of severe recalcitrant nodular acne.

COUMADIN

letter

warfarin Na

tablet

09-218

SLR 098

COUMADIN

letter

warfarin Na

tablet

09-218

SLR 099

May 3

DURICEF

letter

label

cefadroxil monohydrate

capsule

50-528

SLR 018

DURICEF

letter

label

cefadroxil monohydrate

suspension

50-527

SLR 020

DURICEF

letter

label

cefadroxil monohydrate

tablet

50-512

SLR 044

PREVACID

letter

label

lansoprazole

tablet

21-281

SLR 002

PREVACID

letter

label

lansoprazole

suspension

20-406

SLR 045

May 6

ZOCOR

letter

label

simvastatin

tablet

19-766

SLR 051

May 7

LIBRIUM

letter

chlordiazepoxide HCl

injection

12-301

SLR 023

May 8

ESKALITH CR

letter

label

lithium carbonate

tablet

18-152

SLR 016

FLONASE

letter

label

fluticasone propionate

solution

20-121

SLR 020

May 9

NASALIDE

letter

flunisolide

solution

18-148

SLR 035

NASAREL

letter

flunisolide

solution

20-409

SLR 011

IMITREX

letter

label

sumatriptan succinate

nasal spray

20-626

SLR 006

QVAR

letter

beclomethasone dipropionate HFA

aerosol

20-911

SE5 005

Efficacy Claim: For maintenance treatment of asthma in children 5 through 11 years of age

May 10

RETIN-A MICRO

letter

label

tretinoin

gel

20-475

SE2 008

Efficacy Claim: For topical application for the treatment of acne vulgaris

TRILAFON

letter

label

perphenazine

injection

11-213

SLR 024

TRILAFON

letter

label

perphenazine

tablet

10-775

SLR 031

AVELOX

letter

label

moxifloxacin

tablet

21-085

SLR 012

AVELOX

letter

label

moxifloxacin

injection

21-277

SLR 003

CAMPTOSAR

letter

label

irinotecan HCl

injection

20-571

SLR 016

May 16

DIABINESE

letter

chlorpropamide

tablet

11-641

SLR 060

NOLVADEX

letter

label

tamoxifen citrate

tablet

17-970

SLR 049

ZOLOFT

letter

label

sertraline

tablet

19-839

SE1 039

Efficacy Claim: For use in the treatment of Premenstrual Dysphoric Disorder (PMDD)

ZOLOFT

letter

label

sertraline

solution

20-990

SE1 007

Efficacy Claim: For use in the treatment of Premenstrual Dysphoric Disorder (PMDD)

ACTONEL

letter

label

risedronate

tablet

20-835

SE2 009

May 17

Efficacy Claim: For once-a-week dosing of 35 mg tablet and for the treatment and prevention of postmenopausal osteoporosis

CYTOMEL

letter

label

liothyronine Na

tablet

10-379

SLR 047

TIMENTIN

letter

ticarcillin disodium/clavulanate K

injection

50-590

SLR 027

May 20

TRIOSTAT

letter

label

liothyronine Na

injection

20-105

SLR 002

May 22

KEPPRA

letter

label

levetiracetam

tablet

21-035

SLR 019

PLENDIL

letter

label

felodipine

tablet

19-834

SLR 017

DYNABAC

letter

dirithromycin

tablet

50-678

SLR 010

May 23

ERYTHROCIN

letter

erythromycin lactobionate

injection

50-182

SLR 122

FLONASE

letter

label

fluticasone propionate

solution

20-121

SE2 023

Efficacy Claim: For the management of nasal symptoms on an "as needed" or PRN basis in patients for whom the drug is indicated

May 24

VANCOCIN

letter

vancomycin HCl

capsule

50-606

SLR 015

ZITHROMAX

letter

label

azithromycin

tablet

50-710

SLR 011

May 28

NORVASC

letter

label

amlodipine besylate

tablet

19-787

SLR 032

May 30

UNISOM

letter

doxylamine succinate

tablet

18-066

SLR 013

SKELAXIN

letter

metaxalone

tablet

13-217

SLR 044

RESTORIL

letter

temazepam

capsule

18-163

SLR 053

May 31

SONATA

letter

zaleplon

capsule

20-859

SLR 003

MINOCIN

letter

minocycline HCl

capsule

50-649

SLR 011

MINOCIN

letter

minocycline HCl

suspension

50-445

SLR 019

MINOCIN

letter

minocycline HCl

injection

50-444

SLR 036

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