Reference Listed Drug Labeling Supplements Approved in June 2001

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Product name

Links to source documents

Established Name

NDA No.

Supp. No.

Jun 1

CEFAZOLIN AND DEXTROSE

letter

label

cefazolin for injection/dextrose injection

50-779

S-001

Jun 5

LIMBITROL DS

letter

label

chlordiazepoxide/amitriptyline HCl tablets

16-949

S-033

ZEMURON

letter

label

rocuronium bromide injection

20-214

S-013

Jun 6

MENTAX

letter

label

butenafine HCl cream

20-524

S-005

Jun 8

INTEGRILIN

letter

label

eptifibatide injection

20-718

S-013

LIPITOR

letter

label

atorvastatin calcium tablets

20-702

S-025

NICODERM CQ

letter

nicotine transdermal system

20-165

S-019

Jun 11

WELLBUTRIN SR

letter

label

buproprion HCl extended-release tablets

20-358

S-019

Jun 12

COPAXONE

letter

glatiramer acetate injection

20-622

S-022

MINIPRESS

letter

label

prazosin HCl capsules

17-442

S-029

PROTONIX

letter

label

pantoprazole sodium delayed-release tablets

20-987

S-001

Jun 13

SEROSTIM

letter

label

somatropin for injection

20-604

S-014

Jun 14

DALMANE

letter

label

flurazepam HCl capsules

16-721

S-074

Jun 15

PRAVACHOL

letter

label

pravastatin sodium tablets

19-898

S-042

Jun 19

EPIVIR

letter

label

lamivudine tablets

lamivudine oral solution

20-564

20-596

S-013

S-014

ORTHO-CEPT

letter

label

desogestrel/ethinyl estradiol tablets

20-301

S-015

Jun 20

ARICEPT

letter

label

donepezil tablets

20-690

S-016

LEUKERAN

letter

label

chlorambucil tablets

10-669

S-024

MIRALAX

letter

label

polyethylene glycol 3350

20-698

S-003

Jun 21

ACCUPRIL

letter

quinapril HCl tablets

19-885

S-020

Jun 25

HECTOROL

letter

doxercalciferol capsules

20-862

S-001

IMITREX

letter

label

sumatriptan succinate tablets

20-132

S-012

VALTREX

letter

label

valcyclovir HCl tablets

20-550

S-013

VALTREX

letter

label

valcyclovir HCl tablets

20-550

S-012

XENICAL

letter

label

orlistat capsules

20-766

S-007

Jun 26

ORGARAN

letter

danaparoid sodium injection

20-430

S-003

Jun 27

ANDROGEL

letter

label

testerone gel

21-015

S-005

CELEXA

letter

citalopram HBr tablets

20-822

S-011

Jun 28

FML

letter

label

fluorometholone ophthalmic suspension

16-851

S-051

Jun 29

MINTEZOL

letter

label

thiabendazole tablets

thiabendazole oral suspension

16-096

16-097

S-030

S-024