| View |
|
DR-XY38805
|
Azithromycin (As Dihydrate)
|
Azomac
|
200 mg/5mL
|
Powder For Suspension
|
Prescription Drug (Rx)
|
USTP type III Amber Glass Bottle x 15mL and 30mL
|
Antibacterials (Macrolides)
|
General Pharmaceutics Ltd.
|
Bangladesh
|
|
Healol Pharma Corporation
|
Healol Pharma Corporation
|
Automatic Renewal
|
05 October 2022
|
03 December 2027
|
| View |
|
DR-XY38806
|
Azithromycin Dihydrate
|
Azomac
|
500 mg
|
Film Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 3's (Box of 3's);
Alu/Alu Blister Pack x 3's (Box of 6's)
|
Antibacterials (Macrolides)
|
General Pharmaceutics Ltd.
|
Bangladesh
|
|
Healol Pharma Corporation
|
Healol Pharma Corporation
|
Automatic Renewal
|
10 October 2022
|
03 December 2027
|
| View |
|
DR-XY38807
|
Gadopentetate dimeglumine
|
Gadomin
|
469 mg/ mL
|
Solution for Injection (IV)
|
Prescription Drug (RX)
|
USP Type 1 Glass Vial x 10 mL (Box of 1's)
|
-
|
Shanghai Xudong Haipu Pharmaceutical Co., Ltd.
|
China
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
-
|
14 January 2021
|
03 December 2025
|
| View |
|
DR-XY38817
|
Chloramphenicol (As Sodium Succinate)
|
Chloramp
|
1g
|
Powder For Injection (IV)
|
Prescription Drug (RX)
|
Glass vial x 1g (box of 1's and 10's)
|
Antibacterial (Amphenicol)
|
2 World Laboratories
|
India
|
|
2 World Traders Inc.
|
2 World Traders Inc.
|
Automatic Renewal
|
26 April 2021
|
06 December 2025
|
| View |
|
DR-XY38818
|
Norepinephrine (As Bitartrate)
|
Norepin
|
1 mg/mL
|
Concentrate Solution For Infusion
|
Prescription Drug (RX)
|
USP Type I Amber Colored Glass Ampoule in 2 mL, 4
mL per ampoule (Box of 5's) and 10 mL per ampoule (Box of l's)
|
Adrenergic and Dopaminergic Agent
|
United Biotech (P) Limited
|
India
|
|
Delex Pharma International, Inc.
|
Delex Pharma International, Inc.
|
-
|
23 November 2020
|
06 December 2025
|
| View |
|
DR-XY38819
|
Calcium Carbonate + Cholecalciferol (Vit. D3)
|
Calcinol-1000
|
2.5 g / 400 IU
|
Effervescent Granules For Solution
|
Over-the-Counter (OTC)
|
Sachet by 6.7 g
|
-
|
|
|
|
|
|
-
|
02 September 2021
|
09 December 2025
|
| View |
|
DR-XY38833
|
Loperamide Hydrochloride
|
Tgp-Loper
|
2mg
|
Capsule
|
Over-the-Counter (OTC)
|
Clear PVC/Alu Blister Pack x 20's (Box of 100's)
|
-
|
New Myrex Laboratories, Inc.
|
Philippines
|
|
|
TGP Pharma Inc.
|
-
|
27 November 2020
|
08 December 2025
|
| View |
|
DR-XY38847
|
Carvedilol
|
Carvidol
|
6.25mg
|
Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
-
|
Dat Vi Pharmaceutical Joint Stock Company
|
Vietnam
|
|
Singapore Genebio, Inc.
|
Endure Medical, Inc.
|
-
|
14 January 2021
|
09 December 2025
|
| View |
|
DR-XY38855
|
Alprazolam
|
Axal
|
500mcg
|
Tablet
|
Prescription Drug (RX)
|
Alu-PVC Blister Pack of 10's (Box of 30 tablets)
|
Anxiolytic (Benzodiazepine derivative)
|
Amson Vaccines and Pharma (Pvt.) Ltd.
|
Pakistan
|
N/A
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Automatic Renewal
|
26 April 2021
|
27 January 2026
|
| View |
|
DR-XY38856
|
Naproxen Sodium
|
Aprelax
|
550mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
PVC-Alu Blister Pack x 10's (Box of 100's)
|
-
|
Swiss Pharma Resarch Laboratories, Inc.
|
Philippines
|
Blue Sky Trading Co., Inc.
|
|
|
-
|
11 March 2021
|
09 December 2025
|
| View |
|
DR-XY38858
|
Paracetamol + Dextromethorphan Hbr + Phenylephrine Hydrochloride
|
None
|
325 mg/10 mg/5 mg
|
Softgel Capsule
|
Over-The-Counter (OTC)
|
Alu-Clear PVC Blister Pack x 10's (Box of 30's)
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
INNOGEN PHARMACEUTICALS, INC.
|
|
ACTIMED, INC.
|
-
|
07 December 2020
|
09 December 2025
|
| View |
DR-XY38878_PI_01.pdf
|
DR-XY38878
|
Gadobutrol
|
Gadovist
|
1 mmol/mL (equivalent to 604.72 mg/mL)
|
Solution For Intravenous Injection
|
Prescription Drug (RX)
|
5 mL Type I colorless glass pre-filled syringe
|
Paramagnetic Contrast Media
|
Bayer AG
|
Germany
|
|
Bayer Philippines, Inc.
|
|
Renewal
|
22 March 2023
|
08 May 2028
|
| View |
DR-XY38883_PI_01.pdf
|
DR-XY38883
|
Tamsulosin Hydrochloride + Finasteride
|
Tamplus
|
400mcg/5mg
|
Sustained-Release Capsule
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Benign Prostatic Hypertrophy Drug Combination (Alpha-adrenoceptor Antagonist and Testosterone-5
alpha Reductase Inhibitor)
|
Ajanta Pharma Limited
|
India
|
N/A
|
Ajanta Pharma Philippines, Inc.
|
Ajanta Pharma Philippines, Inc.
|
Initial from Monitored Release Extension
|
27 May 2022
|
23 December 2025
|
| View |
|
DR-XY38888
|
Montelukast (As Sodium)
|
Kastel
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack of 10's (Box of 30's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Medhaus Pharma, Inc.
|
|
|
-
|
17 February 2021
|
23 December 2025
|
| View |
DR-XY38889_PI_01.pdf
|
DR-XY38889
|
Tamsulosin Hydrochloride + Finasteride
|
Tamplus
|
200mcg/5mg
|
Sustained-Release Capsule
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Ajanta Pharma Limited
|
India
|
N/A
|
Ajanta Pharma Philippines, Inc.
|
Ajanta Pharma Philippines, Inc.
|
Initial from Monitored Release Extension
|
27 May 2022
|
23 December 2025
|
| View |
DR-XY38890_PI_01.pdf
|
DR-XY38890
|
Olmesartan medoxomil + Amlodipine (as besilate) + Hydrochlorothiazide
|
Tri-Alzor
|
20 mg/5 mg/12.5 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Angiotensin II Receptor Blocker Combination
|
Ajanta Pharma Limited
|
India
|
Ajanta Pharma Philippines, Inc.
|
|
|
Initial from Monitored Release Extension
|
26 May 2022
|
23 December 2025
|
| View |
|
DR-XY38892 (For Export Only)
|
Ketoconazole
|
Healthcare Antifungal Cream
|
2% (20 mg/g)
|
Cream
|
Prescription Drug (RX)
|
Aluminum Tube x 10 g (Box of 1's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
|
|
|
-
|
15 December 2020
|
23 December 2025
|
| View |
|
DR-XY38894
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazovex
|
2g/250mg
|
Powder For Iv Injection
|
Prescription Drug (RX)
|
12mL USP Type III Glass Vial in Individual Box (Box of 10's)
|
-
|
North China Pharmaceutical Co., Ltd.
|
China
|
|
Sannovex Pharmaceutical Distributor
|
Sannovex Pharmaceutical Distributor
|
-
|
21 January 2020
|
06 January 2025
|
| View |
|
DR-XY38895
|
Prednisolone
|
Pred 20
|
20 mg/5 mL
|
Syrup
|
Prescription Drug (RX)
|
Amber Bottle x 30 mL & 60 mL
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Prosel Pharmaceuticals & Distributors, Inc.
|
|
|
-
|
07 December 2020
|
28 December 2025
|
| View |
|
DR-XY38898
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Ciltamin 750
|
750mg
|
Powder For Injection (Im/Iv)
|
Prescription Drug (RX)
|
USP Type I Glass Vial w/ green coloured flip-off seal
|
Antibacterial (Penicillin)
|
Samjin Pharmaceutical Co., Ltd.
|
Korea
|
|
Natrapharm, Inc.
|
Natrapharm, Inc.
|
Renewal
|
05 August 2023
|
28 December 2028
|