View |
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DR-XY41215
|
Pregabalin
|
Funxion
|
75 mg
|
Capsule
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 30's)
|
Antiepileptic
|
Ajanta Pharma Limited
|
India
|
N/A
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Initial (from Monitored Release Extension)
|
19 September 2022
|
11 September 2025
|
View |
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DR-XY41216
|
Pregabalin
|
Funxion
|
150 mg
|
Capsule
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 30's)
|
Antiepileptic
|
Ajanta Pharma Ltd.
|
India
|
N/A
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Initial [from Monitored Release]
|
30 May 2022
|
11 September 2025
|
View |
|
DR-XY41217
|
Amisulpride
|
Amiabel
|
400 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-clear PVC Blister Pack X 10's (Box of 30's)
|
Antipyschotics (Benzamides)
|
Amherst Laboratories, Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
Automatic Renewal
|
28 September 2022
|
19 September 2027
|
View |
|
DR-XY41218
|
METHYL SALICYLATE + MENTHOL + EUGENOL
|
ULTRA-RUB
|
102 mg/ 54.40 mg/ 13.60 mg per g
|
Cream
|
Over-the-Counter (OTC) Drug
|
25g Collapsible Tube in a Box
|
Topical Analgesics
|
The United Drug (1996) Co., Ltd.
|
Thailand
|
N/A
|
SINGAPORE GENEBIO, INC.
|
Endure Medical, Inc.
|
Renewal
|
10 August 2022
|
10 December 2027
|
View |
|
DR-XY41219
|
Amisulpride
|
Amiabel
|
200 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-clear PVC Blister Pack X 10's (Box of 30's)
|
Antipyschotics (Benzamides)
|
Amherst Laboratories Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
Automatic Renewal
|
08 September 2022
|
19 September 2027
|
View |
|
DR-XY41221
|
Azithromycin (As Dihydrate)
|
Zithrobbas
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 4's (Box of 4's)
|
-
|
Harmann Pharmaceutical Labs. (Pvt.) Ltd.
|
Pakistan
|
|
Raquel Abbas Pharmaceuticals and General Merchandise
|
Raquel Abbas Pharmaceuticals and General Merchandise
|
-
|
21 February 2020
|
11 September 2024
|
View |
DR-XY41226_PI_01.pdf
|
DR-XY41226
|
Nilotinib (As Hydrochloride Monohydrate)
|
Tasigna
|
150 mg
|
Capsule
|
Prescription Drug (RX)
|
Clear PVC/PVDC-Alu Blister Pack x 4's (Box of 28's
and 112's)
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
|
Novartis Healthcare Philippines, Inc
|
Novartis Healthcare Philippines, Inc
|
-
|
29 September 2020
|
26 November 2025
|
View |
|
DR-XY41234
|
Calcium Sennosides
|
Slimbalance
|
13.34mg
|
Film-Coated Tablet
|
Over-The-Counter (OTC)
|
Plister pack of 10's
|
Laxative
|
Hua-shin Chemical Pharmaceutical Work. Co., Ltd.
|
Taiwan
|
|
CS TRADING
|
CS TRADING
|
Automatic Renewal
|
12 September 2022
|
11 September 2027
|
View |
|
DR-XY41236
|
Ambroxol Hydrochloride
|
Broxolan
|
30mg/5mL
|
Syrup
|
Over-The-Counter (OTC)
|
Amber round Glass Bottle x 60 mL (Box of 1's)
|
-
|
Doctor's Pharmaceuticals, Inc.
|
Philippines
|
|
|
|
-
|
28 October 2019
|
11 September 2024
|
View |
|
DR-XY41240
|
Montelukast (As Sodium)
|
Aurohex
|
5 mg
|
Chewable Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Leukotriene Receptor Antagonist
|
Flamingo Pharmaceuticals Ltd.
|
India
|
|
Hexagon Pharmaceuticals Hexagon
|
Hexagon Pharmaceuticals Hexagon
|
Renewal
|
20 June 2022
|
11 September 2027
|
View |
|
DR-XY41242
|
Olanzapine
|
Olzadin
|
10mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC White Opaque Blister Pack x 10's (Box of 30's)
|
Atypical Antipsychotics
|
Sydenham Laboratories Inc
|
Philippines
|
Medchoice CNS Pharma Corporation
|
|
|
Renewal
|
27 May 2022
|
11 September 2027
|
View |
|
DR-XY41243
|
Allopurinol
|
Aurinol
|
100mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/ Clear PVC Blister Pack x 10's (Box of 100's)
|
Antigout
|
Pharmasant Laboratories Co., Ltd.
|
Thailand
|
N/A
|
Endure Medical, Inc.
|
N/A
|
Automatic Renewal (Revalidation)
|
22 February 2022
|
13 September 2027
|
View |
|
DR-XY41244
|
Balanced Multiple Maintenance Solution With 5% Dextrose (For Pedia)
|
Endusol-Imb
|
Formulation: Each 500 mL contains:
Electrolytes in 500 ml: Dextrose Monohydrate
Sodium 125 mmol Sodium Acetate, Anhydrous
Potassium 10 mmol Potassium Chloride
705 mg
Magnesium 0.75 mmol Sodium Phosphate Monobasic
Acetate 11.5 mmol Magnesium Chloride Hexahydrate 152.5 mg Chloride 11 mmol Monopotassium Phosphate
Phosphate 1.5 mmol Sodium Metabisulfite Water for Injection
q.s. 500 ml
945 mg
107 mg
75 mg 100 mg
Each 100 mL contains: Dextrose Monohydrate Sodium Acetate, Anhydrous Potassium Chloride Sodium Phosphate Monobasic Magnesium Chloride Hexahydrate Monopotassium Phosphate Sodium Metabisulfite (approx.. 1. Immol/L)
5g 189 mg 141 mg 21.4 mg 30.5 mg 15 mg 20 mg
Electrolytes in 1000 mL Sodium 25 mmol Potassium 20 mmol Magnesium 1.5 mmol Acetate 23 mmol Chloride 22 mmol Phosphate 3 mmol
|
Solution For Intravenous Infusion
|
Prescription Drug (RX)
|
5-layer Co-extrusion Infusion bag
|
Rehydration Solutions
|
Shanxi Nuocheng Pharm'l Co., Ltd.
|
China
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
Automatic Renewal
|
28 September 2022
|
13 September 2027
|
View |
|
DR-XY41245
|
Hydroquinone
|
Dominakrem
|
40 mg
|
Topical Cream
|
Prescription Drug (RX)
|
Aluminum Tube x 10g
|
Other Dermatological
|
Phil Inter Pharma Co., Ltd.
|
Vietnam
|
|
ROJAN TRADERS UNLIMITED, INC.
|
ROJAN TRADERS UNLIMITED, INC.
|
Automatic Renewal
|
22 September 2022
|
13 September 2027
|
View |
|
DR-XY41250
|
Candesartan Cilexetil
|
Torcand-8
|
8 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/alu blister pack x 10's (Box of 30's)
|
ANTIHYPERTENSIVE (ANGIOTENSIN II RECEPTOR BLOCKER)
|
Torrent Pharmaceuticals Limited
|
India
|
|
Torrent Pharma Philippines, Inc.
|
Torrent Pharma Philippines, Inc.
|
Automatic Renewal
|
08 July 2022
|
19 September 2027
|
View |
|
DR-XY41252
|
Esomeprazole (As Magnesium)
|
Nexpro-40
|
40 mg
|
Enteric-Coated Tablet
|
Prescription Drug (RX)
|
ALU/ALU BLISTER PACK X 10'S
|
PROTON PUMP INHIBITOR
|
Torrent Pharmaceuticals Limited
|
India
|
|
Torrent Pharmaceuticals Inc.
|
Torrent Pharmaceuticals Inc.
|
Automatic Renewal
|
08 July 2022
|
19 September 2027
|
View |
|
DR-XY41253
|
Gemcitabine (As Hydrochloride)
|
Gembio
|
1g
|
Lyophilized Powder for IV Infusion
|
Prescription Drug (RX)
|
USP Type I Clear Glass Vial (Box of 1's)
|
-
|
Intas Pharmaceuticals Ltd.
|
India
|
|
Singapore Genebio, Inc.
|
Endure Medical, Inc.
|
-
|
24 February 2021
|
19 September 2025
|
View |
|
DR-XY41254
|
Gemcitabine (As Hydrochloride)
|
Gembio
|
200mg
|
Lyophilized Powder for IV Infusion
|
Prescription Drug (RX)
|
USP Type I Clear Glass Vial (Box of 1's)
|
-
|
Intas Pharmaceuticals Ltd.
|
India
|
|
Singapore Genebio, Inc.
|
Endure Medical, Inc.
|
-
|
16 February 2021
|
19 September 2025
|
View |
|
DR-XY41255
|
5% Dextrose In 0.3% Sodium Chloride
|
None
|
None
|
Solution For Intravenous Infusion
|
Prescription Drug (RX)
|
5 Layer Co-extrusion bag
|
Rehydration Solutions
|
Shanxi Nuocheng Pharm'l Co., Ltd.
|
China
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
Automatic Renewal
|
28 September 2022
|
19 September 2027
|
View |
|
DR-XY41256
|
Ketamine (As Hydrochloride)
|
Etamine
|
50 mg/mL
|
Solution For Injection
|
Prescription Drug (RX)
|
USP Type III amber glass vial
|
General Anesthetic
|
Swiss Parenterals Pvt. Ltd.
|
India
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
Automatic Renewal
|
05 September 2022
|
19 September 2027
|