Legal Supplement Part B-Vol. 33, No. 154

Legal Supplement Part B-Vol. 33, No. 154

Legal Supplement Part B-Vol. 33, No. 154-25th July, 1994
277
LEGAL NOTICE No. 137
REPUBLIC OF TRINIDAD AND TOBAGO
APPROVAL IN RESPECT OF NEW DRUGS
(Food and Drugs Act, Chap. 30:01)
IN EXERCISE of the powers conferred on him under section 7, Division 3,
Second Schedule of the Food and Drugs Regulations, the Minister of
Health, acting on the advice of the Drug Advisory Committee, has
issued Notices of Approval in respect of the New Drugs listed
hereunder:
Trade Name and Form
Manufacturer
Country of
Origin
Condition
of Sale
United States
of America
Third
Schedule
Indomethacin Capsules
USP 25 mg
W arner-Chilcott Labs
Division of WarnerLambert Company
Indomethacin Capsules
USP50mg
do.
do.
do.
Carbamazepine Chewable
Tablets 100 mg
do.
do.
do.
Sulindac Tablets
USP 150mg
do.
do.
do.
Sulindac Tablets
USP 200 mg
do.
do.
do.
Propranolol Hydrochloride
and Hydrochlorothiazide
Tablets USP 40 mg/25 mg
do.
do.
do.
Propranolol Hydrochloride
and Hydrochlorothiazide
Tablets USP 80 mg/25 mg
do.
do.
do.
Clonidine Hydrochloride
Tablets USP 0.1 mg
do.
do.
do.
Clonidine Hydrochloride
Tablets USP 0.2 mg
do.
do.
do.
Clonidine Hydrochloride
Tablets USP 0.3 mg
do.
do.
do.
Albuterol Sulfate
Tablets 2 mg
do.
do.
do.
Albuterol Sulfate
Tablets 4 mg
do.
do.
do.
Methyldopa and
Hydrochlorothiazide
Tablets USP
250 mg/15 mg
do.
do.
do.
278
Approval in Respect of New Drugs
Trade Name and Form
Manufacturer
Country of
Origin
Condition
of Sale
United States
of America
Third
Schedule
Methyldopa and
Hydrochlorothiazide
Tablets USP
250 mg/25 mg
Warner-Chilcott Labs
Division of WarnerLambert Company
Methyldopa and
Hydrochlorothiazide
Tablets USP
500 mg/30 mg
do.
do.
do.
Methyldopa and
Hydrochlorothiazide
Tablets USP
500 mg/50 mg
do.
do.
do.
Flurazepam
Hydrochloride
Capsules USP 15 mg
do.
do.
Controlled
Drug
Flurazepam
Hydrochloride
Capsules USP 30 mg
do.
do.
do.
. Tenormin Tablets 100 mg
(change in name of
manufacturer)
United
Kingdom
Zeneca Limited
Third
Schedule
Zestoretic Tablets
(change in name of
manufacturer)
do.
do.
do.
Zestril Tablets 5 mg
(change in name of
manufacturer)
do.
do.
do.
Zestril Tablets 10 mg
(change in name of
manufacturer)
do.
do.
do.
Zestril Tablets 20 mg
(change in name of
manufacturer)
do.
do.
do.
Tenoretic Tablets
(change in name of
manufacturer)
do.
do.
do.
Tenoret 50 Tablets
(change in name of
manufacturer)
do.
do.
do.
Kytril Ampoules 3 mg
Smith Kline
Beecham
Pharmaceuticals
...
England
do.
Approval in Respect of New Drugs
Trade Name and Form
Country of
Origin
Manufacturer
Diprivan 1% w/v
Intravenous Injection
(change in name of
manufacturer)
Kabi Pharmacia
AB Sweden for
Zeneca Limited
Diamicron Tablets
(change in formulation)
Les Laboratoires
Servier
Denazox 30 Tablets
Remedica Ltd.
279
Condition
of Sale
United
Kingdom
...
Third
Schedule
France
do.
Cyprus
do.
Denazox 60 Tablets
do.
do.
do.
Priaxen 250 Tablets
do.
do.
do.
Iopamiron 300 Injection
ScheringAG
Pharmaceutical
Division
Bisacodyl U.S.P.
Suppositories
Technilab Inc.
Acetazone Forte Tablets
Germany
...
Steris Laboratories
Inc.
Testosterone Cypionate
Injection 200 mg/ml
Your Life Maximum Choice
High Potency Vitamin
and Mineral Formula
Time Release Tablets
Free Sale
do.
United States
of America
do.
do.
P. Leiner Nutritional
Products Inc.
do.
do.
do.
Your Life Balanced High
Potency B-150 Tablets
...
do.
do.
Vitamin B Complex 100
Injection
Canada
do.
Third
Schedule
do.
...
Free Sale
do.
Tilcotil Tablets 20 mg
(change of source, change
of name)-formerly
Mobiflex Tablets
F. HoffmaunLa Roche Ltd.
Switzerland
Benzac AC Wash 21/o
Galderma Laboratories
Inc.
United States
of America
Benzac AC Wash 10
do.
do.
do.
N asacort Nasal Inhaler
Rhone-Poulenc Rorer
Pharmaceuticals Inc.
do.
Third
Schedule
Maalox HRF Suspension
Cool Mint Flavor
do.
do.
Free Sale
MJ.alox HRF Tablets
Cool Mint Flavor
do.
do.
Cilest Tablets
...
CilagLtd.
...
Switzerland
Third
Schedule
...
Free Sale
do.
Third
Schedule
280
Approval in Respect of New Drugs
Trinovum Tablets
Country of
Origin
Manufacturer
Trade Name and Form
... CilagLtd.
Switzerland
Condition
of Sale
Third
Schedule
Solaquin Forte 4% Gel
ICN Pharmaceuticals
Inc.
United States
of America
do.
Piportil L4 Ampoules
100mg/4ml
Theraplix RhonePoulenc Rorer
France
do.
do.
do.
Piportil L4 Ampoules
25mg/1ml
do
Robaxin Tablets 500 mg
.. . A. H. Robins Company
Gammar-N Immune
Globulin Intravenous
(Human) 1g
Armour
Pharmaceutical
Company
United States
of America
do.
do.
do.
Gammar-N Immune
Globulin Intravenous
(Human) 2.5 g
do.
do.
do.
Gammar-N Immune
Globulin Intravenous
(Human) 5.0 g
do.
do.
do.
Denmark
do.
do.
do.
One-Alpha Capsules
0.25 meg
One-Alpha Capsules
1mcg
Leo Pharmaceutical
Products
do.
Epoc 500 Pure Oil of Evening
Primrose with Vitamin E
Capsules 500 mg
Evening Primrose Oil
Company
Rapicaine 2 % with
Epinephrine 1:
100,000 Injection
UnipharmSA
Taxol Injection 30 mg/5 m1
Bristol Caribbean Inc.,
for Bristol-Myers
Squibb Co.
Puerto Rico
do.
Dormicum Tablets 7.5 mg
F. Hoffmann-La Roche Ltd.
Switzerland
do.
Batrafen Nail Lacquer
Hoechst AG, Germany
packed by Quimica
Hoechst de Guatemala
Guatemala
do.
Timed Release Maximum
Strength Women's Ultra
Mega Multiple Vitamins
and Minerals Tablets
General Nutrition
Corporation
United States
of America
do.
...
United
Kingdom
Free Sale
Guatemala
Third
Schedule
"
'
281
Approval in Respect of New Drugs
Manufacturer
Trade Name and Form
General Nutrition
Corporation
Timed Release Mega Men
Tablets
do.
Timed Release Maximum
Strength Ultra Mega II
Multiple Vitamins and
Minerals Tablets
Country of
Origin
Condition
of Sale
United States
of America
Third
Schedule
do.
Vifor (International) Inc. . .. Switzerland
Hausmann Ferrum
Chewable Tablets
do.
... Free Sale
Hausmann Ferrum
Fol Chewable Tablets
do.
do.
do.
Ferrum Hausmann Drops
(change in name of
manufacturer)
do.
do.
do.
Ferrum Hausmann Syrup
(change in name of
manufacturer)
do.
do.
do.
Sansilla Solution
(change in name of
manufacturer)
do.
do.
do.
Hausmann Ferrum
Intravenous Ampoule
100 mg (change in name
of manufacturer)
do.
do.
Third
Schedule
Hausmann Ferrum
Intramuscular Ampoule
100 mg (change in name
of manufacturer)
do.
do.
do.
do.
do.
do.
do.
Roferon-A
3 Mio IU Ampoules
(change of source)
F. Hoffmann-La Roche Ltd.
Roferon-A
9 Mio IU Ampoules
(change of source)
do.
C + Rose Hips Vitamin C1000 mg with Rose Hips
Tablets
Daypro Caplets 600 mg
Basic Organics Inc.
.. . G. D. Searle & Co.
United States
of America
do.
Free Sale
Third
Schedule
Platosin Injection 1 mg/ml ... Pharmachemie B.V.
Holland
do.
Zoloft Capsules 50 mg
Canada
do.
Pfizer Canada Inc.
282
Approval in Respect of New Drugs
Trade Name and Form
Manufacturer
Country of
Origin
Muscle Rub
Extra Strength Cream
Clay-Park Labs Inc.
United States
of America
Condition
of Sale
Free Sale
Maximum Strength
Acne Cleansing Pads
do.
do.
do.
Therapeutic Blue Gel
do.
do.
do.
Medicated Skin Cream
Greaseless
do.
do.
do.
do.
do.
Nature's Cleanser
Herbal Programme
#1 Rejuvenator Formula
(change in formulation)
Nature's Cleanser
VETERINARY PRODUCT
Tasmix Effervescent
Vitamin Tablets
Pitman-Moore Inc.
United States ... Free Sale
of America
Dated this 14th day of July, 1994.
E. PILGRIM
Permanent Secretary,
Ministry of Health