Better Sleep Articles >> Sleep Drugs And SupplementsButisol sodium and the FDAPOSTED: July 28, 2007 10:37 amDEPARTMENT OF HEALTH & HUMAN SERVICES
NDA 0-793/S-015
Public Health Service
Food and Drug Administration
Rockville MD 20857
Wallace Laboratories
Division of Carter-Wallace, Inc.
Attention: llona J. Scott
Half Acre Road/ P.O. Box 1001
Cranbury, NJ 08512-0181
NOV 4 1998
Dear Ms. Scott:
Please refer to your supplemental new drug application (S-015) dated November 5, 1985,
received November 12,1985, submitted under section 505(b) of the Federal Food, Drug,
and Cosmetic Act for Butisol Sodium (butabarbital Sodium Tablets) 15 mg, 30 mg, 50 mg,
and 100 mg.
Supplemental application S-015 provides for the voluntary listing of inactive ingredients in
the DESCRIPTION section of labeling. The specific additions are as follows:
Other ingredients in the Tablets are: calcium stearate, corn starch, dibasic
calcium phosphate, FD&C Blue No. 1 (15 mg and 30 mg only), FD&C Blue
No. 2 (100 mg only), FD&C Red No. 3 (15 mg and 100 mg only), FD&C
Yellow No. 5 (30 mg and 50 mg only - see Precautions), FD&C Yellow No.
6 (100 mg only). Other ingredients in the Elixir are: D&C Green No. 5,
edetate disodium, FD&C Yellow No. 5 (See Precautions, flavors (natural,and
artificial),propylene glycol, purified water, saccharin sodium, sodium
benzoate.
Labeling changes of the kind which you have proposed under S-015 are permitted by
section 314.70(c) of the regulations to be made prior to approval of the supplement. It is
understood that the changes described in S-034 have been.implemented.
We have completed the review of this supplemental application and have concluded that
adequate information has been presented to demonstrate that the drug product is safe and
effective for use as recommended in the final printed labeling (copy code IN-01 10-01)
submitted on November 4, 1985. Accordingly, the supplemental application is approved,
effective as of the date of this letter.
We remind you that you must comply with the requirements for an approved NDA set forth
under 21 CFR 314.80 and 314.81.
NDA 0-793/S-015
If you have any questions concerning this NDA, please contact Mr. Merril Mille, R.Ph.,
Senior Regulatory Management Officer, at (301) 594-5528.
Paul Leber, M.D.
Director
Division of Neuropharmacological Drug Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
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