| View |
|
DRP-6758-17
|
Paracetamol + Vitamin B-Complex
|
Amko-B Plus
|
500 mg/50 mg/100 mg/100 mcg
|
Film-Coated Tablet
|
Analgesic/ Antipyretic/ Vitamin
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
04 January 2024
|
18 February 2029
|
| View |
|
HRP-530
|
Hydroquinone + Tretinoin
|
Blanc by Beautederm Acne Banishing Toner
|
1 g/10 mg per 100 mL (1%/0.010% w/v)
|
Topical Solution
|
-
|
DJM Grandeur Corporation
|
Philippines
|
Initial (HR)
|
19 July 2022
|
19 July 2027
|
| View |
|
DR-XY48210
|
Levodropropizine
|
Levotic CR
|
90 mg
|
Controlled-Release Tablet
|
Cough Suppressant
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release (MR) (Re-application)
|
21 July 2022
|
21 July 2027
|
| View |
|
DRP-12360
|
Dabigatran Etexilate (as mesylate)
|
Gribero
|
75 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
MSN Laboratories Private Limited
|
India
|
Initial [Re-application]
|
25 July 2022
|
25 July 2027
|
| View |
|
DRP-12359
|
Dabigatran Etexilate (as mesylate)
|
Gribero
|
110 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
MSN Laboratories Private Limited
|
India
|
Initial [Re-application]
|
25 July 2022
|
25 July 2027
|
| View |
|
DRP-12367
|
Lamotrigine
|
Lamtac 100
|
100mg
|
Tablet
|
Antiepileptic
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
26 July 2022
|
26 July 2027
|
| View |
|
DR-XY48228
|
Ciprofloxacin (As Lactate)
|
Ciprobay
|
2 mg/mL
|
Solution for Intravenous (IV) Infusion
|
Antibacterial (Fluroquinolone)
|
Fresenius Kabi Italia S.R.L.
|
Italy
|
Initial (Correction)
|
30 July 2024
|
26 July 2027
|
| View |
|
DRP-12371
|
Acetylcysteine
|
Synucil
|
100 mg
|
Granules for Oral Solution
|
Mucolytic
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 July 2022
|
27 July 2027
|
| View |
|
DRP-12372
|
Acetylcysteine
|
Nacsyd
|
100 mg
|
Granules for Oral Solution
|
Mucolytic
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 July 2022
|
27 July 2027
|
| View |
|
DRP-12328
|
Metformin hydrochloride + Sitagliptin (as phosphate)
|
Sitagli Plus 1050
|
1 g/50 mg
|
Film-Coated Tablet
|
-
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
15 July 2022
|
15 July 2027
|
| View |
|
DR-XY48219
|
Docetaxel
|
None
|
20 mg/mL (80 mg / 4 mL)
|
Concentrate For Solution For IV Infusion
|
Antineoplastic (Taxane)
|
Venus Remedies, Limited
|
India
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
|
DRP-12341
|
Levocetirizine Dihydrochloride
|
None
|
5 mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine Derivative)
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48197
|
Olmesartan Medoxomil + Amlodipine (As Besilate)
|
Alzor CCB
|
20mg/10mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Calcium
Blocker Combination
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 July 2022
|
18 July 2027
|
| View |
|
DRP-11780
|
Vancomycin (as Hydrochloride)
|
Philvan
|
500 mg
|
Lyophilized Powder for IV Infusion
|
Antibacterial (Glycopeptide)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
|
DR-XY48202
|
Pantoprazole (As Sodium Sesquihydrate)
|
None
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 July 2022
|
18 July 2027
|
| View |
|
THPR-60
|
Vaccinium macrocarpan Ait. L. (Cranberry fruit juice
refined dry extract)
|
Ellura
|
206 mg
|
Capsules
|
Prevention of
recurrent uncomplicated acute urinary tract infections
(cystitis) in adult women.
|
Soho Flordis International Switzerland SA
|
Switzerland
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DRP-12348
|
Levofloxacin (as hemihydrate)
|
Aculev
|
5 mg/mL (500 mg/100 mL)
|
Solution for Intravenous
Infusion
|
Antibacterial (Fluoroquinolone)
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
|
DRP-12286
|
Nintedanib
|
Veganib 100
|
100 mg
|
Soft Gel Capsule
|
Antineoplastic (protein kinase inhibitor)
|
Sun Pharmaceutical Industries ltd.
|
India
|
Initial (Reconstruction)
|
28 June 2024
|
22 July 2027
|
| View |
|
DR-XY48196
|
Elobixibat (as monohydrate)
|
Goofice
|
5mg
|
Film-Coated Tablet
|
Ileal Bile Acid Transporter Inhibitor
|
EA Pharma Co., Ltd. (Fukushima Plant)
|
Japan
|
Monitored Release
|
18 July 2022
|
18 July 2027
|
| View |
|
DRP-12361
|
Palonosetron (as hydrochloride)
|
Ferant
|
50 mcg/mL (250 mcg/5 mL)
|
Solution for Intravenous
Injection
|
Antiemetic/Antinauseant [Serotonin (5HT3) Antagonist]
|
Medochemie Ltd. (Ampoule Injectable Facility)
|
Cyprus
|
Initial
|
25 July 2022
|
25 July 2027
|