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Reference Listed Drug Labeling Approved in October 2000

Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.  Click on the product name to view the approved labeling changes in Adobe Acrobat PDF Doc format.

  Product Established Name NDA/Supp no.

Oct 2

MOTRIN IB ibuprofen tablets

19-012/S-024

ANECTINE succinylcholine chloride injection

08-453/S-019


Oct 3

TRACRIUM atracurium besylate injection

18-831/S-022

CHLOROPTIC chloramphenicol ophthalmic solution

50-091/S-008

MIRCETTE desogestrel and ethinyl estradiol tablets

20-713/S-007

ARTHROTEC diclofenac sodium/misoprostol tablets

20-607/S-005


Oct 4

SANDIMMUNE cyclosporine oral solution

50-573/S-018

SANDIMMUNE cyclosporine capsules

50-574/S-025

SANDIMMUNE cyclosporine injection

50-625/S-027

NEORAL cyclosporine capsules [modified]

50-716/S-011

NEORAL cyclosporine oral solution [modified]

50-715/S-007

ALTACE ramipril capsules

19-901/S-028


Oct 5

PLAQUENIL hydroxychloroquine sulfate tablets

09-768/S-033


Oct 6

LESCOL fluvastatin sodium capsules

20-261/S-028

NTG IN DEXTROSE 5% nitroglycerin injection

19-970/S-011


Oct 10

CARDURA doxazosin mesylate tablets

19-668/S-014

LOZOL indapamide tablets

18-538/S-026


Oct 12

NEURONTIN gabapentin oral solution

20-235/S-015

NEURONTIN gabapentin capsules

21-129/S-005

NEURONTIN gabapentin tablets

20-882/S-002


Oct 17

DOLOPHINE methadone HCl injection

06-134/S-023

SINGULAIR montelukast sodium chewable tablets

20-830/S-010

SINGULAIR montelukast sodium tablets

20-829/S-009


Oct 20

FOSAMAX alendronate sodium tablets

20-560/S-021

BIAXIN clarithromycin tablets

50-662/S-029


Oct 23

CRIXIVAN indinavir sulfate capsules

20-685/S-045


Oct 27

SEROSTIM somatropin for injection

20-604/S-010


Oct 31

CAFERGOT ergotamine tartrate/caffeine supp

09-000/S-021

TALACEN pentazocine HCl/acetaminophen tablets 18-458/S-010

FDA/Center for Drug Evaluation and Research
Last Updated: November 01, 200118 Jan 2006 17:16:43 -0500
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