View |
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DRP-11844
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Oxytocin
|
Syntomax
|
5 IU per mL
|
Concentrate for Solution for Injection (IV)
|
Posterior Pituitary Lobe Hormone
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
06 May 2022
|
06 May 2027
|
View |
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DR-XY37620
|
Aceclofenac
|
Airtal
|
100 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Industrias Farmaceuticas Almirall, S.A.
|
Spain
|
Initial (from Monitored Release Extension (MRE) status)
|
10 May 2022
|
16 March 2025
|
View |
DRP-11846_PI_01.pdf
|
DRP-11846
|
Citicoline
|
Citikar
|
250 mg/mL
|
Solution for Injection (I.M./I.V)
|
Psychostimulant/Nootropic
|
Sakar Healthcare Ltd.
|
India
|
Initial [Rx]
|
10 May 2022
|
10 May 2027
|
View |
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DRP-11804
|
Timolol (as Maleate)
|
Optinova
|
5 mg/mL (0.5% w/v)
|
Sterile Ophthalmic Solution (Drops)
|
Antiglaucoma preparation and miotic (Beta blocking
agent)
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial
|
06 May 2022
|
06 May 2027
|
View |
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DRP-11829
|
Betamethasone (as Dipropionate)
|
Zydip
|
500 mcg per gram (0.05% w/w)
|
Topical Cream
|
Corticosteroid
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
06 May 2022
|
06 May 2027
|
View |
|
DRP-2742-14
|
Guaifenesin + Salbutamol (As Sulfate)
|
Nasalife
|
50 mg/1 mg per 5 mL
|
Syrup
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Initial
|
06 May 2022
|
25 November 2025
|
View |
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DRP-6278-07
|
Guaifenesin + Salbuttamol (As Sulfate)
|
Hikacure
|
100mg/2mg
|
Capsule
|
Selective Beta-2-Adrenoreceptor Agonist/Expectorant
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Automatic Renewal
|
17 October 2022
|
05 October 2027
|
View |
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DRP-11850
|
Cefazolin (As Sodium)
|
None
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
Initial
|
10 May 2022
|
10 May 2027
|
View |
DR-XY48011_PI_01.pdf
|
DR-XY48011
|
Imiquimod
|
Aldara
|
50mg/g (5% w/w)
|
Topical cream
|
Antiviral
|
Ensign Laboratories Pty. Ltd.
|
Australia
|
Initial
|
11 May 2022
|
28 April 2027
|
View |
|
DRP-11852
|
Captopril
|
Saphril
|
25 mg
|
Tablet
|
Ace Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
10 May 2022
|
10 May 2027
|
View |
|
DRP-11838
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
None
|
2g/250mg
|
Powder for Solution for Infusion
|
Antibacterial
|
Laboratorio Reig Jofre S.A.
|
Spain
|
Automatic Renewal (Variation: PCPR Conversion)
|
06 May 2022
|
24 April 2027
|
View |
|
DRP-11859
|
Zoledronic Acid
|
Lendrozo
|
4mg/5mL
|
Solution for IV Infusion
|
Biphosphonate
|
Shilpa Medicare Limited
|
India
|
Initial
|
11 May 2022
|
11 May 2027
|
View |
|
DRP-8865-01
|
Diosmin + Hesperidin
|
Varicure
|
450mg/50mg
|
Film-Coated Tablet
|
Vasoprotective
|
XL Laboratories Pvt. Ltd.
|
India
|
Renewal
|
04 August 2024
|
19 May 2030
|
View |
|
DRP-6492-09
|
Paracetamol + Orphenadrine Citrate
|
Norpriexia Forte
|
650 mg/35mg
|
Film-Coated Tablet
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
Initial
|
19 March 2021
|
18 January 2026
|
View |
|
DRP-6493-06
|
Paracetamol + Orphenadrine Citrate
|
Norpriexia
|
450 mg/35 mg
|
Film-Coated Tablet
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
Initial
|
21 June 2021
|
18 January 2026
|
View |
|
DR-XY47291
|
Diclofenac Potassium
|
Dolofast
|
50mg
|
Powder For Oral Solution
|
-
|
Mipharm S.p.A.
|
Italy
|
Monitored Release
|
31 May 2021
|
31 May 2026
|
View |
|
DRP-4164-25
|
Cefuroxime (As Axetil)
|
Goxetil
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Brawn Laboratories Limited
|
India
|
Automatic Renewal
|
24 March 2022
|
27 December 2027
|
View |
|
DRP-4555-08
|
Cilostazol
|
Clostelo 50
|
50 mg
|
Tablet
|
Platelet Aggregation Inhibitor
|
Cadila Pharmaceuticals Limited
|
India
|
Automatic Renewal
|
31 March 2022
|
09 December 2027
|
View |
|
DRHR-2139
|
Ethyl Alcohol
|
Gentle Care
|
0.7
|
70% Solution
|
Antiseptic / Disinfectant
|
J. Chemie Laboratories, Inc.
|
Philippines
|
Renewal
|
07 April 2024
|
20 May 2029
|
View |
|
DR-XY48025
|
Multivitamins + Mineral
|
Conzace
|
Each softgel capsule contains: Ascorbic Acid (Vitamin C)-500mg dl-Alpha Tocopheryl Acetate (Vitamin E)-100 IU Retinol Palmitate (Vitamin A)-5000 IU Zinc (equivalent to 69mg Zinc Sulfate Monohydrate)-25mg
|
Softgel Capsule
|
Vitamins / Mineral
|
Belmont Softgel Pharma Corporation
|
Philippines
|
Initial (OTC)
|
20 May 2022
|
20 May 2027
|