View |
DRP-10727_PI_01.pdf
|
DRP-10727
|
Amoxicillin (as trihydrate)
|
Vaxman
|
250 mg / 5 mL
|
Powder For Suspension
|
ANTIBACTERIAL (PENICILLIN)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
-
|
18 March 2022
|
22 May 2027
|
View |
DRP-9932_PI_01.pdf
|
DRP-9932
|
Budesonide
|
Budecort Respules
|
500 mcg/mL (1000 mcg/2 mL)
|
Nebulizing Suspension
(Sterile)
|
Drugs for obstructive airway disease (Glucocorticoid)
|
AstraZeneca AB (PET Blow Fill Seal Facility)
|
Sweden
|
Initial (Variation)
|
05 August 2022
|
05 August 2027
|
View |
DRP-10705_PI_01.pdf
|
DRP-10705
|
Budesonide + Formoterol fumarate dihydrate
|
Neumoterol
|
200 mcg/6 mcg
|
Dry Powder for Inhalation
|
Adrenergic-Corticosteroid Combination
|
Laboratorios Liconsa, S.A.
|
Spain
|
Monitored Release
|
10 November 2021
|
10 November 2026
|
View |
DRP-10704_PI_01.pdf
|
DRP-10704
|
Budesonide + Formoterol fumarate dihydrate
|
Neumoterol
|
400 mcg/12 mcg
|
Dry Powder for Inhalation
|
-
|
Laboratorios Liconsa, S.A.
|
Spain
|
-
|
10 November 2021
|
10 November 2026
|
View |
|
DR-XY47547
|
Progesterone
|
Utrogestan
|
100 mg
|
Oral Soft-gel Capsule
|
-
|
Cyndea Pharma S.L.
|
Spain
|
-
|
19 November 2021
|
19 November 2026
|
View |
|
DR-XY47548
|
Progesterone
|
Utrogestan
|
200 mg
|
Vaginal Soft-gel Capsule
|
-
|
Cyndea Pharma S.L.
|
Spain
|
-
|
19 November 2021
|
19 November 2026
|
View |
|
DRP-6337-03
|
Buclizine hydrochloride + Vitamin B-Complex + Iron
|
Apevit
|
Formulation: Each 5 mL contains: Buclizine hydrochloride-5mg Thiamine hydrochloride (Vitamin B1)-10mg Pyridoxine hydrochloride (Vitamin B6)-5mg Cyanocobalamin (Vitamin B12)-10mcg Ferrous sulfate (equivalent to 10 mg elemental Iron)-50 mg
|
Syrup
|
-
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
-
|
15 November 2021
|
28 September 2025
|
View |
|
DR-XY47562
|
Celecoxib
|
Lecox-200
|
200 mg
|
Capsule
|
Non-steroidal Anti-inflammatory and Antirheumatic (Coxib)
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial (Re-issuance)
|
04 August 2022
|
23 November 2026
|
View |
|
DR-XY47556
|
Silver Sulfadiazine
|
Sulfadex
|
10 mg/g (1%w/w)
|
Topical Cream
|
-
|
Dong Wha Pharm Co., Ltd.
|
Korea
|
-
|
22 November 2021
|
22 November 2026
|
View |
|
DR-XY47524
|
Escitalopram (As Oxalate)
|
Jovia
|
20 mg
|
Film-coated Tablet
|
-
|
Bilim Ilaç San. Ve Tic. A.Ş.
|
Turkey
|
-
|
15 November 2021
|
15 November 2026
|
View |
|
DR-XY 47531
|
Zinc Orotate
|
Zinkorot
|
25mg
|
Tablet
|
-
|
Mauermann - Arzneimittel KG
|
Germany
|
-
|
15 November 2021
|
15 November 2026
|
View |
DR-XY47527_PI_01.pdf
|
DR-XY47527
|
Azelastine hydrochloride + Fluticasone propionate
|
Dymista
|
137 mcg/50 mcg per actuation
|
Nasal Suspension
(Spray)
|
Anti-allergic Agent-Corticosteroid Combination
|
Cipla Ltd.
|
India
|
Monitored Release
|
10 November 2021
|
10 November 2026
|
View |
|
DRHR-2098
|
Cineole + Eucalyptus + Menthol + Camphor +
Rosemary Oil
|
None
|
60mg/60mg/50mg/49mg/10mg per g
|
Ointment
|
-
|
Felton Grimwade & Bosisto's Pty Ltd
|
Australia
|
-
|
19 November 2021
|
19 November 2025
|
View |
|
DRP-3183-06
|
Losartan (As Potassium)
|
None
|
50 mg
|
Film Coated Tablet
|
Angiotensin-II-Receptor Blocker (ARB)
|
XL Laboratories Pvt. Ltd.
|
India
|
Renewal
|
18 May 2022
|
07 June 2027
|
View |
|
DRP-4977-01
|
Dextrose In Water
|
None
|
0.05
|
Solution for IV Infusion
|
Electrolyte Replenisher
|
Albert David Limited
|
India
|
CLIDP
|
09 November 2021
|
13 September 2026
|
View |
|
DRP-4854-11
|
Esomeprazole (As Sodium)
|
None
|
40 mg
|
Lyophilized Powder For Injection (I.V.)
|
Proton Pump Inhibitor
|
Brawn Laboratories Limited
|
India
|
Automatic Renewal
|
13 February 2023
|
23 October 2028
|
View |
|
DRP-4145-09
|
Betahistamine Dihydrochloride
|
Convergo-24
|
24 mg
|
Tablet
|
Antivertigo
|
Synmedic Laboratories
|
India
|
Automatic Renewal
|
12 September 2022
|
13 December 2027
|
View |
|
DRP-5349-01
|
Finasteride
|
Dima
|
1 mg
|
Film-Coated Tablet
|
Testosterone-5-Alpha Reductase Inhibitor
|
Sydler Remedies Pvt. Ltd.
|
India
|
Renewal
|
01 February 2024
|
18 June 2029
|
View |
|
DRP-3711-03
|
Ciprofloxacin (As Hydrochloride)
|
Cifrextab 750
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Quinolone)
|
XL Laboratories Pvt. Ltd.
|
India
|
-
|
13 April 2022
|
24 July 2027
|
View |
|
DRP-6810-08
|
Co-Amoxiclav
|
Cassanoxiclav-AR
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin + Beta-Lactamase Inhibitor
Combination)
|
Uni Medicolabs Inc.
|
India
|
CLIDP
|
26 November 2021
|
26 August 2026
|