Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Notices 14289

Sunflower oil (unhydrogenated)

(identification)

Talc (description, identification, extractable

fluoride)

Tannic acid (definition, heavy metals, loss on

drying)

Terpene resin, natural (heavy metals)

Terpene resin, synthetic (heavy metals)

Thiamine mononitrate (assay)

Thiamine hydrochloride (assay)

L-Threonine (specific rotation)

DL-α-Tocopherol (lead, heavy metals)

d-α-Tocopherol concentrate (description,

heavy metals, lead)

Tocopherols concentrate, mixed (description,

heavy metals, lead)

DL-α-Tocopheryl acetate (lead, heavy metals)

d-α-Tocopheryl acetate (heavy metals, lead)

d-α-Tocopheryl acetate concentrate

(description, heavy metals, lead)

d-α-Tocopheryl acid succinate (heavy metals,

lead)

Tragacanth (heavy metals, lead)

L-Tryptophan (description, specific rotation)

L-Tyrosine (specific rotation)

L-Valine (specific rotation)

Vitamin B12 (identification, assay)

Vitamin D2 (identification)

Vitamin D3 (identification)

Xanthan gum (ash, heavy metals)

Xylitol (lead)

Yeast extract ([formerly Autolyzed yeast

extract] description, requirements, assay,

other tests)

Zinc gluconate (numerous changes)

Interested persons may, on or before

April 17, 1995, submit to NAS (address

above) written comments regarding the

monographs listed in this notice. Those

wishing to make comments are

encouraged to submit supporting data

and documentation with their

comments. Two copies of any comments

are to be submitted. Comments and

supporting data or documentation are to

be identified with the docket number

found in brackets in the heading of this

document and should include a

statement that it is in response to this

Federal Register notice. NAS will

forward a copy of each comment to the

Dockets Management Branch (address

above). Received comments may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: March 3, 1995.

L. Robert Lake,

Acting Director, Center for Food Safety and

Applied Nutrition.

[FR Doc. 95–6529 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0063]

Dey Laboratories, et al.; Withdrawal of

Approval of 14 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 14 abbreviated new drug

applications (ANDA’s). The holders of

the ANDA’s notified the agency in

writing that the drug products were no

longer marketed and requested that the

approval of the applications be

withdrawn.

EFFECTIVE DATE: April 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Carolyn C. Harris, Center for Drug

Evaluation and Research (HFD–360),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–1038.

SUPPLEMENTARY INFORMATION: The

holders of the ANDA’s listed in the table

in this document have informed FDA

that these drug products are no longer

marketed and have requested that FDA

withdraw approval of the applications.

The applicants have also, by their

request, waived their opportunity for a

hearing.

ANDA no. Drug Applicant

70–805 .......... Metaproterenol Sulfate Inhalation Solution, U.S.P., 5% ........................ Dey Laboratories, 2751 Napa Valley Corporate Dr.,

Napa, CA 94558.

80–086 .......... Sulfadiazine Tablets, 167 milligrams (mg) Sulfamerazine Tablets, 167

mg Sulfamethazine Tablets, 167 mg.

Purepac Pharmaceutical, Co., 200 Elmora Ave., Elizabeth, NJ 07207.

80–120 .......... Isoniazid Tablets, 100 mg ...................................................................... Towne, Paulsen & Co., Inc., 14527 South San Pedro

St., Gardena, CA 90248.

80–132 .......... Isoniazid Tablets, U.S.P. ....................................................................... Purepac Pharmaceutical, Co.

80–276 .......... Testosterone Propionate Injection ......................................................... Elkins-Sinn, Inc., 2 Esterbrook Lane, Cherry Hill, NJ

08003–4099.

80–308 .......... Methyltestosterone Buccal Tablets, 10 mg ........................................... Purepac Pharmaceutical, Co.

80–309 .......... Methyltestosterone Tablets, 10 mg ....................................................... Do.

80–310 .......... Methyltestosterone Tablets, 25 mg ....................................................... Do.

80–459 .......... Hyrocortisone Emulsion Cream, 1% ...................................................... Elder Pharmaceuticals, Inc., ICN Plaza, 3300 Highland

Ave., Costa Mesa, CA 92626.

80–475 .......... Methyltestosterone Tablets .................................................................... Purepac Pharmaceuticals, Inc.

80–489 .......... Hydrocortisone Ointment, 0.5% ............................................................. Altana Inc., 60 Baylis Rd., Melville, NY 11747.

80–581 .......... Pyridoxine Hydrochloride Injection U.S.P., 100 mg/milliliter (mL) ......... Elkins-Sinn, Inc.

80–797 .......... Chlorpheniramine Maleate Injection, 10 mg/mL and 100 mg/mL ......... Do.

80–928 .......... Propantheline Bromide Tablets, 15 mg ................................................. Geneva Pharmaceuticals, Inc., 2555 West Midway

Blvd., Broomfield, CO 80038–0446.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the ANDA’s listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective April 17, 1995.

Dated: March 2, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–6426 Filed 3-15–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which