View |
|
DR-XY47631
|
Pramipexole dihydrochloride (as monohydrate)
|
Pridel
|
1 mg
|
Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
Micro Labs Limited
|
India
|
Initial
|
23 December 2021
|
23 December 2026
|
View |
|
DR-XY47632
|
Pramipexole dihydrochloride (as monohydrate)
|
Pridel
|
250 mcg
|
Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
Micro Labs Limited
|
India
|
Initial
|
23 December 2021
|
23 December 2026
|
View |
|
DR-XY47633
|
Tadalafil
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
27 December 2021
|
27 December 2026
|
View |
DR-XY47634_PI_01.pdf
|
DR-XY47634
|
Remdesivir
|
Covifor
|
100mg
|
Lyophilized Powder For Solution For I.V Injection
|
-
|
Aspiro Pharma Limited
|
India
|
-
|
27 December 2021
|
27 December 2024
|
View |
|
DR-XY47636
|
Clotrimazole
|
Candigo
|
100 mg
|
Vaginal Suppository
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
-
|
28 December 2021
|
28 December 2026
|
View |
|
DR-XY47637
|
Clotrimazole
|
Candigo
|
500 mg
|
Vaginal Suppository
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
-
|
28 December 2021
|
28 December 2026
|
View |
|
DR-XY47639
|
Ascorbic Acid + Zinc
|
Novazinc
|
500 mg (equivalent to 562.4 mg Sodium Ascorbate)/10 mg (30.25 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Novagen Pharmaceutical Co., Inc.
|
Philippines
|
Initial
|
27 January 2022
|
27 January 2027
|
View |
|
DR-XY47640
|
Sodium Bicarbonate + Sodium Citrate + Citric Acid +
Tartaric Acid
|
Citrix Soda
|
1.76 g/630 mg/720 mg/890 mg per sachet
|
Effervescent Granules
|
-
|
Bliss GVS Pharma Ltd.
|
India
|
-
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47641
|
Co-Amoxiclav
|
Xinclav 625
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillins)
|
Aurobindo Pharma Limited (Unit XII)
|
India
|
-
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47642
|
Co-Amoxiclav
|
Xinclav 1000
|
1000 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillins)
|
Aurobindo Pharma Limited (Unit XII)
|
India
|
-
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47643
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Immunforte
|
500 mg (equivalent to 562.43 mg Sodium
Ascorbate) 10 mg (equivalent to 70 mg Zinc
Gluconate)/1000 IU
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47644
|
Vino De Quina
|
None
|
20 mg (equivalent to 100 mg Ferrous Sulfate
Heptahydrate)/15 mg per 30 mL Solution (Peppermint
Flavor)
Formulation:
Each 30 mL solution contains: Iron..
..20 mg equivalent to 100 mg Ferrous Sulfate (as Heptahydrate)] Thiamine Hydrochloride.
.....15 mg
|
Solution
|
-
|
Maridan Industries, Inc
|
Philippines
|
-
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47645
|
Multivitamins + Minerals + Amino Acids + Vitis
vinifera L. (Grape) Seed
|
None
|
Each tablet contains: Beta Carotene (Vitamin A) Retinyl Palmitate (Vitamin A) Cholecalciferol (Vitamin D3) Ascorbic Acid (Vitamin C) d-Alpha Tocopheryl Succinate (Vitamin E) Pantothenic Acid (as D-Calcium Pantothenate) Niacin (Vitamin B3)
Thiamine (Vitamin B1) Riboflavin (Vitamin B2) Pyridoxine HCI (Vitamin B6) Biotin (Vitamin B7) Folic Acid (Vitamin B9) Cobalamin (Vitamin B12) Calcium Phosphorus Magnesium
12,500 IU Potassium 12,500 IU Zinc
200 IU Iron
80mg Copper 15 IU Manganese 15mg Selenium 10mg Chromium
5mg Molybdenum Smg Methylsulfonylmethane (MSM) 5mg L-methionine
Img Citrus Bioflavonoid Complex 200mcg Alpha Lipoic Acid
7.5mcg Silica
135mg Choline 100mg Inositol
50mg Vitis vinifera L. (Grape) Seed (Leucoselect)
25mg 12.5mg
5mg
Img 500mcg 100mcg 100mcg 25mcg 125mg 50mg 50mg 50mg 40mg 25mg 25mg
15mg
|
Tablet
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial [OTC]
|
29 December 2021
|
29 December 2026
|
View |
|
DR-XY47646
|
Amoxicillin (as Trihydrate)
|
None
|
250mg
|
Capsule
|
-
|
Fortis Medi Pharmaceutical, Inc.
|
Philippines
|
-
|
07 January 2022
|
07 January 2027
|
View |
|
DR-XY47647
|
Cefriaxone (as sodium)
|
None
|
1g
|
Powder for Injection (IV Infusion)
|
-
|
Nipro Pharma Corporation Odate Plant
|
Japan
|
-
|
07 January 2022
|
07 January 2027
|
View |
|
DR-XY47648
|
Salbutamol(as sulfate) + Ipratropium Bromide
|
Iprax-Mol
|
2.5 mg + 500 mcg
|
SOLUTION FOR INHALATION
|
Beta2-adrenergic agonist/anticholinergic combination
|
Axa Parenterals Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
View |
|
DR-XY47649
|
Per Kit contains:
Sitagliptin (as phosphate monohydrate) 50 mg Film Coated Tablet + Metformin hydrochloride 1 g
Extended Release Tablet
|
Adivia Met
|
Per Kit contains:
Sitagliptin (as phosphate monohydrate) 50 mg Film Coated Tablet + Metformin hydrochloride 1 g
Extended Release Tablet
|
Dipeptidyl peptidase 4 (DPP-4) inhibitor/ Oral
Hypoglycemic (Biguanide)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
07 January 2022
|
07 January 2027
|
View |
|
DR-XY47650
|
Alfuzosin hydrochloride
|
Adzosin
|
10 mg
|
Sustained-Release Tablets
|
Alpha-adrenoreceptor antagonist
|
Aurobindo Pharma Limited - Unit III
|
India
|
Initial
|
19 January 2022
|
19 January 2027
|
View |
|
DR-XY47651
|
Zinc Oxide + Myroxylon balsamum var. pereirae
(Royle) Harms (Balsam of Peru) Resin + Benzyl
Benzoate
|
Anucare
|
107.5mg/18.8mg/12.5mg per g Ointment
|
Ointment
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
-
|
05 January 2022
|
05 January 2027
|
View |
|
DR-XY47652
|
Eugenol
|
None
|
1 mg/mL
|
Solution (Toothache Drops)
|
-
|
Vonwelt, Inc.
|
Philippines
|
-
|
06 January 2022
|
06 January 2027
|