View |
|
DRP-11169
|
Tranexamic Acid
|
Hemanex
|
500 mg
|
Capsule
|
Anti-Fibrinolytic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
View |
|
DR-XY47699
|
Haloperidol Decanoate
|
Haldol Decanoas
|
50 mg/mL
|
Solution For Injection (IM)
|
Antipsychotic
|
Janssen Pharmaceutica NV
|
Belgium
|
Initial
|
31 January 2022
|
31 January 2027
|
View |
|
DRP-1944
|
Hyoscine-N-Butylbromide
|
Gutzid
|
10 mg
|
Tablet
|
Anticholinergic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
21 February 2024
|
22 March 2029
|
View |
|
DRP-11170
|
Fexofenadine Hydrochloride
|
Fexonov-180
|
180 mg
|
Tablet
|
Antihistamine
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
08 February 2022
|
08 February 2027
|
View |
|
DRP-11205
|
Benzoyl Peroxide
|
Benzomed
|
50mg/g (5% w/w)
|
Topical Gel
|
-
|
Blossom Pharmaceuticals
|
India
|
-
|
11 February 2022
|
11 February 2027
|
View |
|
DR-XY43857
|
Labetalol hydrochloride
|
Abetol
|
5 mg/mL (100 mg/20 mL)
|
Solution for Injection (IV)
|
Alpha and Beta Blocking Agent
|
Swiss Parenterals Ltd.
|
India
|
Renewal
|
25 July 2024
|
07 November 2029
|
View |
|
DRP-11191
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Piprazin
|
4 g/500 mg
|
Powder for Injection (IV)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
11 February 2022
|
11 February 2027
|
View |
|
DR-XY28774
|
Calcitriol
|
Osteomeg
|
0.25 mcg
|
Softgel Capsule
|
-
|
Mega Lifesciences Public Company Limited
|
Thailand
|
-
|
31 January 2022
|
11 July 2025
|
View |
|
DR-XY41539
|
Ascorbic Acid + Zinc (as gluconate)
|
Asconvita Plus
|
Formulation: Each 5mL of Syrup contains: Ascorbic Acid-44.5 mg Ascorbic Acid (as Sodium Ascorbate)-44.5 mg (equivalent to 50 mg Sodium Ascorbate) Zinc (as gluconate)-10 mg
|
Syrup
|
-
|
Doctors Pharmaceuticals, Inc.
|
Philippines
|
-
|
02 February 2022
|
28 December 2024
|
View |
|
DRP-11171
|
Tranexamic Acid
|
Xed
|
100 mg/mL
|
Solution For Injection (IV)
|
Antifibrinolytic
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
08 February 2022
|
08 February 2027
|
View |
|
DRP-11142
|
Iron Sucrose
|
None
|
363.64 mg/mL (equivalent to 20 mg elemental Iron)
|
Solution for Injection (I.V.)
|
-
|
Mylan Laboratories Limited (Hosur Sterile Facility)
|
India
|
-
|
07 February 2022
|
07 February 2027
|
View |
|
DRP-7669
|
Paracetamol
|
None
|
500 mg
|
Tablet
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
-
|
31 January 2022
|
27 March 2025
|
View |
|
DRP-11115
|
Ceftriaxone (as Sodium)
|
Unitiaxone
|
2g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Union Korea Pharm Co., Ltd.
|
Korea
|
Initial
|
03 February 2022
|
03 February 2027
|
View |
|
DR-XY47698
|
Menthol + Glycyrrhiza glabra (Liquorice root) +
Zingiber officinale (Ginger rhizome) + Phyllanthus
emblica (Indian gooseberry fruit)
|
Vicks VapoDrops
|
7 mg/15 mg/10 mg/10 mg
|
Lozenges (Berry Menthol Flavor)
|
Throat preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
31 January 2022
|
31 January 2027
|
View |
|
DR-XY47727
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7mg/15mg/10mg/10mg Lozenge (Honey Lemon
Menthol Flavor)
|
Lozenges
|
-
|
Unique Pharmaceutical Laboratories (Division of J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
-
|
11 February 2022
|
11 February 2027
|
View |
|
DR-XY47726
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks Vapo Drops
|
7mg/15mg/10mg/10mg
|
Lozenge (Orange Menthol
Flavor)
|
-
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
-
|
11 February 2022
|
11 February 2027
|
View |
|
DRP-11164
|
Piperacillin (As Sodium) + Tazobactam (As Sodium)
|
Glopitam
|
4 g/500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 February 2022
|
08 February 2027
|
View |
|
DRP-11114
|
Olanzapine
|
Olanz 5
|
5 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
03 February 2022
|
03 February 2027
|
View |
|
DRP-11163
|
Piperacillin (As Sodium) + Tazobactam (As Sodium)
|
Piptazo 2.5
|
2g / 250 mg
|
Powder For Injection (IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
08 February 2022
|
08 February 2027
|
View |
|
DRP-11162
|
Piperacillin (As Sodium) + Tazobactam (As Sodium) + Wfi
|
Piptazo 4.5
|
4g / 500 mg
|
Powder For Injection (IV)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 February 2022
|
08 February 2027
|