| View |
|
DRP-12946
|
Phytomenadione
|
Kedion
|
10 mg/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Suicheng Pharmaceutical Co., Ltd.
|
China
|
PCPR Conversion
|
10 November 2022
|
21 July 2027
|
| View |
|
DRP-12954
|
Adapalene
|
Adana
|
1mg/g (0.1% w/w)
|
Topical Gel
|
-
|
Rhydburg Pharmaceutical Limited
|
India
|
PCPR Conversion
|
10 November 2022
|
29 November 2026
|
| View |
|
DRP-12939
|
Valsartan
|
Balsartec-160
|
160 mg
|
Film Coated tablet
|
-
|
Micro Labs Limited
|
India
|
PCPR Conversion
|
08 November 2022
|
03 March 2027
|
| View |
|
DRP-12937
|
Valsartan
|
Balsartec -80
|
80 mg
|
Film Coated Tablet
|
-
|
Micro labs Limited
|
India
|
PCPR Conversion
|
08 November 2022
|
03 March 2027
|
| View |
|
DRP-12941
|
Metformin Hydrochloride+ Pioglitazone ( as Hydrochloride ) + Glimepiride
|
Tripride-2
|
500 mg/25 mg/2 mg
|
Tablet
|
-
|
Micro Labs Limited
|
India
|
PCPR Conversion
|
08 November 2022
|
02 October 2025
|
| View |
|
DRP-12928
|
0.9% SODIUM CHLORIDE
|
NIR-NS
|
(see reverse for formulation)
|
Solution for I.V. Infusion
|
ELECTROLYTE REPLENISHER
|
Aculife Healthcare Pvt. Ltd
|
India
|
Renewal
|
10 March 2023
|
23 April 2028
|
| View |
|
DRP-12927
|
0.9% Sodium Chloride
|
None
|
0.9% (w/v)
|
Solution for Irrigation
|
-
|
Aculife Healthcare Pvt. Ltd
|
India
|
-
|
05 November 2022
|
23 June 2025
|
| View |
|
DR-XY48431
|
Acetylcysteine
|
Solbriz
|
200 mg
|
Powder for Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
HRP-552
|
Povidone-Iodine
|
Maxi-Aid
|
0.1
|
Topical Solution
|
Antiseptic
|
Primecare Lifesciences Laboratories Corp.
|
Philippines
|
Initial (HR)
|
25 October 2022
|
25 October 2027
|
| View |
|
DRP-12892
|
5% Dextrose in Lactated Ringer's Solution
|
One-Dex DSLR
|
Formulation: Each 100 mL solution contains: Sodium chloride-600mg Sodium lactate-310mg Potassium chloride-30mg
Calcium chloride-20mg Dextrose-5g Water for Injection-q.s.
|
Solution for I.V. Infusion
|
Electrolyte Replenisher
|
Abaris Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12918
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine
Hydrochloride (Vitamin B ) + Cyanocobalamin (Vitamin B12)
|
Nervesaph-Max
|
500 mg / 250 mg / 1 mg
|
Film-Coated Tablet
|
Vitamins
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|
| View |
DR-XY48448_PI_01.pdf
|
DR-XY48448
|
Fexuprazan Hydrochloride
|
Fexuclue
|
40mg
|
Film-Coated Tablet
|
Potassium-competitive acid blocker (P-CAB)
|
Daewoong Pharmaceutical Co., Ltd.
|
South Korea
|
Monitored Release
|
03 November 2022
|
03 November 2027
|
| View |
|
DR-XY48446
|
Multivitamins + Herbs + Inositol + Choline
|
None
|
Formulation Each capsule contains: Thiamine Mononitrate (Vitamin B1)-50mg Riboflavin (Vitamin B2)-50mg Niacinamide (Vitamin B3)-50mg Pyridoxine Hydrochloride (Vitamin B6)-50mg Folic Acid (Vitamin B9)-400mcg Cyanocobalamin (Vitamin B12)-50mcg Biotin (Vitamin B7)-50 mcg Pantothenic Acid (Vitamin B5)-50mcg Inositol-50 mg Choline (Choline Bitartrate)-21mg
Herbal Powdered Blend contains:
3.5mg Laminaria digitata (Kelp) Plant Malpighia emarginata (Acerola Extract Complex) Fruit Medicago sativa (Alfalfa) Leaf and Stem Petroselimm crispum (Parsley) Stem) Rosa acicularis Lindi (Rose Hips) Fruit Nasturtium officinale (Watercress) Herb
|
Capsule
|
-
|
Solgar, Inc.
|
United States of America
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12909
|
Etoricoxib
|
Bico-90
|
90 mg
|
Film-Coated Tablet
|
Non-Steroid Antiinflammatory and Antirheumatic Product
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DRHR-2164
|
Glycerin
|
United Home Glydolax
|
1.9g
|
Rectal Suppository
|
Laxative
|
Am-Europharma Corporation
|
Philippines
|
Initial (Correction)
|
23 May 2023
|
25 October 2027
|
| View |
|
DR-XY48453
|
Paracetamol + Ibuprofen
|
Maselax
|
325mg / 200mg
|
Capsule
|
Antipyretic/Analgesic/Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Saga Laboratories
|
India
|
Initial (OTC)
|
04 November 2022
|
04 November 2027
|
| View |
|
DR-XY48425
|
Febuxostat
|
Vexbos 80
|
80 mg
|
Film-Coated Tablet
|
Antigout preparation
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DR-XY48426
|
Doxycycline (as hyclate)
|
Dynadoxy
|
100mg
|
Capsule
|
Antibacterial (Tetracycline)
|
Swiss Pharmaceutical Co., Ltd. (Xinshi Plant)
|
Taiwan
|
Initial (Re-appplication)
|
03 November 2022
|
03 November 2027
|
| View |
|
DRP-12856
|
Valsartan
|
Valtir
|
80 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12902
|
Amlodipine (as besilate)
|
None
|
10mg
|
Tablet
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
Globela Pharma Private Limited
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|