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DR-XY48665_PI_01.pdf
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DR-XY48665
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Inclisiran (as sodium)
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Sybrava
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284 mg/1.5 mL
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Solution for Injection (SC)
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-
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Corden Pharma Societa' Per Azioni
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Monitored Release
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23 March 2023
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23 March 2028
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DRP-13700
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Alfuzosin Hydrochloride
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Fuzotral
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10 mg
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Extended-Release Tablet
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-
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Stallion Laboratories Pvt. Ltd.
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Initial
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29 March 2023
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29 March 2028
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DRP-13628
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Diclofenac Sodium
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Blifec
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25 mg/mL (75 mg/3 mL)
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Solution For Injection (I.M.)
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-
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Makcur Laboratories Limited
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Initial
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23 March 2023
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23 March 2028
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DR-XY48678
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Icatibant
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Firazyr
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10 mg/mL (30 mg/3 mL)
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Solution For Injection (SC)
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-
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Vetter Pharma-Fertigung GmbH & Co. KG
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Monitored Release
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29 March 2023
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29 March 2028
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DRP-13688
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Multivitamins + Minerals + Chorella Growth Factor
(CGF)
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Hiteens
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FORMULATION:
Each 5mL contains:
Ascorbic Acid (Vitamin C) 100 mg
Retinol (Vitamin A) 500 mcg
Niacin (Vitamin B1)15 mg
Colecalciferol (Vitamin D)
10 mcg
Thiamine (Vitamin B1)
5 mg
Cyanocobalamin (Vitamin B12)10 mcg
Riboflavin (Vitamin B2)5 mg
Taurine 50 mg
Pyridoxine (Vitamin B6) 5 mg
Lysine 30 mg
Pantothenic Acid (Vitamin B5) 3.2 mg
Chlorella Growth Factor (CGF) 50 mg
Alpha-tocopherol (Vitamin E) 1 mg
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Syrup
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-
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Enicar Pharmaceuticals Pvt. Ltd.
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Initial
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29 March 2023
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29 March 2028
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DRP-13648
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Multivitamins + Minerals + Chorella Growth Factor
(CGF)
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Kiddigrow
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FORMULATION:
Each Capsule contains:
Ascorbic Acid (Vitamin C)100 mg
Niacinamide (Vitamin B3)24 mg
Calcium Phosphate 150 mg Copper Sulfate 1 mg
Retinol (Vitamin A) 1925 IU
Taurine 200 mg
Colecalciferol (Vitamin D) 210 IU
Iron 17 mg
Riboflavin (Vitamin B2) 1.95 mg
Zinc 9 mg
Pyridoxine (Vitamin B6) 1.95 mg
Magnesium Oxide 7.50 mg
Thiamine (Vitamin B1) 1.80 mg
Folic Acid 250 mcg
Cyanocobalamin (Vitamin B12) 3 mcg
Chlorella Growth Factor (CGF) 200 mg
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Capsule
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-
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Sapphire Lifesciences Pvt. Ltd.
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Initial
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29 March 2023
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29 March 2028
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DR-XY48679
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Peritoneal Dialysis Solution with 2.3% Dextrose
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CAPD/DPCA 19 Stay Safe Link
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Formulation:
Each L of Solution contains:
Glucose (Dextrose) -22.73 g
equivalent to 25 g glucose monohydrate
Sodium Chloride -5.786 g
Sodium Lactate -3.925 g
Calcium chloride dihydrate -0.1838 g
Magnesium chloride hexahydrate-0.1017 g
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Peritoneal Dialysis Solution
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-
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Fresenius Medical Care Production Sdn. Bhd.
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Initial
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29 March 2023
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29 March 2028
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DRP-13663
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Fentanyl (as citrate)
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Blifan
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50 mcg/mL (100 mcg/ 2 mL)
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Solution for Injection
(I.M./I.V.)
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-
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Alwin DMD Pharmaceuticals
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Initial
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23 March 2023
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23 March 2028
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DRP-13635
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Gentamicin (as sulfate)
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Gentamite
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40 mg/mL (80 mg/ 2 mL)
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Solution for Injection (I.M./I.V.)
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-
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Swiss Parenterals Ltd. (Block-B)
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Initial
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21 March 2023
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21 March 2028
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DRP-13639
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Ketoconazole + Clobetasol (as propionate)
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Acceketosol
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10 mg/500 mcg per gram
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Topical Cream
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-
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Opal Laboratories (Pvt.) Limited
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Initial
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22 March 2023
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23 March 2028
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DRP-13696
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Telmisartan + Amlodipine (as besilate)
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Lynsta
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80 mg/10 mg
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Tablet
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-
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Lloyd Laboratories, Inc.
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Initial
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29 March 2023
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29 March 2028
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DRP-13697
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Telmisartan + Amlodipine (as besilate)
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Lynsta
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40 mg/5 mg
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Tablet
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-
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Lloyd Laboratories, Inc.
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Initial
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29 March 2023
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29 March 2028
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DRP-13634
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Etoricoxib
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Etoxib 120
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120 mg
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Film-Coated Tablet
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-
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Synokem Pharmaceuticals Ltd.
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Initial
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21 March 2023
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21 March 2028
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DRP-13681
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Ursodeoxycholic Acid
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Deoxysaph
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300 mg
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Film-Coated Tablet
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-
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Sapphire Lifesciences Pvt. Ltd.
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Initial
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24 March 2023
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24 March 2028
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DR-XY48660
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Dolutegravir (as sodium) + Lamivudine + Tenofovir
disoproxil fumarate
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None
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50 mg/300 mg/300 mg
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Film-Coated Tablet
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-
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Aurobindo Pharma Limited (Unit VII)
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Monitored Release (Re-application)
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21 March 2023
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21 March 2026
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DRP-13421
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Esomeprazole (as magnesium trihydrate)
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Gastronov-20
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20mg
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Enteric Coated Tablet
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-
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Ratnamani Healthcare Pvt. Ltd.
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Initial (Re-Application)
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22 March 2023
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22 March 2028
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DRP-13420
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Esomeprazole (as magnesium trihydrate)
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Gastronov-40
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40 mg
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Enteric Coated Tablet
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-
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Ratnamani Healthcare Pvt. Ltd.
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Initial (Re-Application)
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22 March 2023
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22 March 2028
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DR-XY48672
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Multivitamins + Minerals
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Berocca Energy
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Formulation
Each Effervescent Tablet:
Ascorbic acid (Vitamin C) 500 mg
Calcium (as calcium carbonate and calcium pantothenate) 100 mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100 mg
Nicotinamide (Vit B3) 50 mg
Panthothenic Acid (Vit B5) 23 mg
Thiamine hydrochloride (Vit B1) 15 mg
Riboflavin (Vit B2) 15 mg
Pyridoxine hydrochloride (Vit B6) 10 mg
Folic acid (Pteroylmonoglutamic acid) 10 mg
Zinc (as zinc citrate trihydrate)400 mcg Biotin (Vit H) 150 mcg
Cyanocobalamin (Vit B12) 10 mcg
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Effervescent Tablet
(Mango Flavour)
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-
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PT. Bayer Indonesia
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Initial (OTC)
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29 March 2023
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29 March 2028
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| View |
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DR-XY48673
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Multivitamins + Minerals
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Berocca Energy
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Formulation
Each Effervescent Tablet:
Ascorbic acid (Vitamin C) 500 mg
Calcium (as calcium carbonate and calcium pantothenate) 100 mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100 mg
Nicotinamide (Vit B3) 50 mg
Panthothenic Acid (Vit B5) 23 mg
Thiamine hydrochloride (Vit B1) 15 mg
Riboflavin (Vit B2) 15 mg
Pyridoxine hydrochloride (Vit B6) 10 mg
Zinc (as zinc citrate trihydrate) 10 mg
Folic acid (Pteroylmonoglutamic acid) 400 mcg Biotin (Vit H) 150 mcg
Cyanocobalamin (Vit B12) 10 mcg
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Effervescent Tablet (Orange Flavour)
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Vitamins/Minerals
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PT. Bayer Indonesia
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Indonesia
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Initial (OTC)
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29 March 2023
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29 March 2028
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HRP-572
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Ethyl Alcohol
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Alco-Aid Plus
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70% (v/v)
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Solution
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-
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Primecare Lifesciences Laboratories Corp.
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Initial (OTC)
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21 March 2023
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21 March 2028
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