View |
|
DR-XY48646
|
Docetaxel
|
Brexel 80
|
10 mg/mL (80 mg/ 8 mL)
|
Solution for Injection for I.V. Infusion
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
DRP-13614
|
Rifampicin + Isoniazid
|
Rimactazid 150/75
|
150 mg/75 mg
|
Film-Coated Tablet
|
-
|
Panacea Biotec Limited
|
India
|
Initial
|
17 March 2023
|
17 March 2028
|
View |
|
DRP-13565
|
Palonosetron (as hydrochloride)
|
Palvotron
|
50 mcg/mL (250 mcg/ 5 mL)
|
Solution for I.V. Injection
|
-
|
USV Private Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
DRHR-2216
|
Methyl Salicylate + Menthol + Camphor
|
Katinko
|
2g/2g/2g per 100 mL
|
Liniment (Ginger and Patchuli Oil Scent)
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
DR-XY48655
|
Evogliptin (as tartrate)
|
Suganon
|
5 mg
|
Film-Coated Tablet
|
-
|
Dong-A ST Co., Ltd.
|
Korea
|
Monitored Release
|
16 March 2023
|
16 March 2028
|
View |
|
DR-XY48645
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Baulivit-B
|
100 mg/100 mg/100 mcg
|
Capsule
|
-
|
Bauch Phils. Laboratories, Inc.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2025
|
View |
|
DRP-13580
|
Pantoprazole (as sodium sesquihydrate) +
Domperidone
|
None
|
40mg / 30mg
|
Modified Release Capsule
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
13 March 2023
|
13 March 2025
|
View |
|
DR-XY48648
|
Acetylcysteine
|
Fluicin
|
600mg
|
Effervescent Tablet
|
-
|
Millimed Co., Ltd. (Branch)
|
Thailand
|
Initial
|
13 March 2023
|
13 March 2028
|
View |
|
HMR-176
|
Blumea balsamifera (L.) DC (Sambong Leaf)
|
Uro-Leaf
|
500 mg
|
Tablet
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
Initial
|
14 March 2023
|
14 March 2028
|
View |
|
DR-XY48658
|
Alfuzosin Hydrochloride
|
Muraxal
|
10 mg
|
Extended-Release Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
20 March 2023
|
20 March 2028
|
View |
|
DRP-13544
|
Calcium Gluconate (as monohydrate)
|
Glucasaph
|
100mg/mL
|
Solution for Injection (IV)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
08 March 2023
|
08 March 2028
|
View |
|
DRP-13579
|
Paracetamol + Caffeine
|
Parasapheine
|
500 mg/65 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
13 March 2023
|
13 March 2028
|
View |
|
HRP-577
|
Sodium Bicorbonate
|
Bicarsaph
|
325 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
13 March 2023
|
13 March 2028
|
View |
|
DRP-13564
|
Fluorouracil
|
Fluorasaph
|
50 mg/mL
|
Solution for I.V. Injection
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
DR-XY48653
|
Ascorbic Acid + Colecalciferol + Zinc
|
Redoxon
|
1 g/400 IU/10 mg
|
Effervescent Tablet (Orange Flavour)
|
-
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13571
|
Amikacin (as sulfate)
|
Unbranded
|
250 mg/mL (500mg/2mL)
|
Solution For Injection (IM/IV)
|
Antibacterial (Aminoglycoside)
|
Concept Pharmaceuticals Ltd.
|
India
|
Renewal
|
12 October 2024
|
10 March 2030
|
View |
|
DRP-13602
|
Thiamine Hydrochloride (Vitamin B1)
|
Vino La Carmina
|
21.5 mg/30 mL
|
Syrup
|
-
|
Ace Pharmaceuticals, Inc.
|
Philippines
|
Initial [OTC]
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13546
|
Nitroglycerin
|
Glytrosaph
|
1 mg/mL
|
Solution For Injection (I.V.)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
08 March 2023
|
08 March 2028
|
View |
|
HRP-573
|
Ethyl Alcohol
|
Alco-Aid Plus
|
70% (v/v)
|
Solution
|
-
|
Primecare Lifesciences Laboratories Corp.
|
Philippines
|
Initial (OTC)
|
20 March 2023
|
20 March 2028
|
View |
|
DRP-13543
|
Metronidazole
|
Trimetro IV
|
5mg/mL
|
Solution for Injection (IV Infusion)
|
-
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
08 March 2023
|
08 March 2028
|