| View |
|
DR-XY31236
|
Racecadotril
|
Hidrasec
|
10 mg
|
Granules For Oral Suspension
|
Prescription Drug (RX)
|
PE/Paper/Aluminum Sachet x 1g (Box of 16's)
|
-
|
Sophartex
|
France
|
|
Abbott Laboratories
|
Zuellig Pharma Corporation
|
-
|
23 July 2020
|
23 November 2025
|
| View |
|
DR-XY31237
|
Racecadotril
|
Hidrasec
|
30 mg
|
Granules For Oral Suspension
|
Prescription Drug (RX)
|
PE/Paper/Aluminum Sachet x 3g (Box of 30's)
|
-
|
Sophartex
|
France
|
Laboratorie Bioprojet Pharma
|
Abbott Laboratories
|
Zuellig Pharma Corporation
|
-
|
24 July 2020
|
23 November 2025
|
| View |
|
DR-XY31241
|
Tobramycin/ Dexamethasone
|
DUOCOM
|
3mg/1mg per mL
|
Ophthalmic Suspension
|
Prescription Drug (RX)
|
5 mL net content in 10 mL HDPE Pilfer guard eye dropper
|
Anti-inflammatory / Anti-infective
|
E.L. Laboratories, Inc.
|
Philippines
|
VISTA PHARMA, INC.
|
|
|
Renewal
|
20 May 2022
|
03 May 2027
|
| View |
|
DR-XY31242
|
Vitamin B-Complex + Vitamin E
|
Neurogen-E
|
See Formulation
|
Tablet
|
Over-The-Counter (OTC)
|
Flex Foil x 4's
|
Vitamin
|
Amherst Laboratories Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
Automatic Renewal
|
08 July 2022
|
19 May 2028
|
| View |
|
DR-XY31256
|
Simvastatin
|
Regumet
|
20mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVC Blister Pack x 10's (Box x 30's)
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
SEA-KING Pharma, Inc.
|
|
|
-
|
18 February 2021
|
16 November 2025
|
| View |
|
DR-XY3126
|
Guaifenesin
|
Clarituss
|
100 mg/5mL
|
Syrup
|
Over-The-Counter (OTC)
|
Amber Bottle x 120mL
|
-
|
San Marino Laboratories Corporation
|
Philippines
|
Pharmacare Products Corporation
|
|
|
-
|
30 January 2020
|
24 January 2025
|
| View |
|
DR-XY31272
|
Iloprost (as trometamol)
|
Ventavis
|
10 mcg/mL
|
Solution for Inhalation
|
Prescription Drug (RX)
|
Type I Colorless Glass Ampoule x 2 mL (Box of 6's)
|
-
|
Berlimed, S.A.
|
Spain
|
|
Bayer Philippines, Inc.
|
|
-
|
23 December 2020
|
13 January 2026
|
| View |
|
DR-XY31275
|
Doxofylline
|
Ansimar
|
100 mg/ 5 mL (2 g/100 mL)
|
Syrup
|
Prescription Drug (RX)
|
Type III yellow amber glass bottle with
Polypropylene (PP) childproof cap + measuring cup x 100 mL (net content). Box of l’s
|
Bronchodilator
|
ABC Farmaceutici S.p.A.
|
Italy
|
|
OEP Philippines, Inc.
|
Zuellig Pharma Corporation
|
Initial (from Monitored Release (MR) status) (Correction)
|
24 January 2023
|
23 November 2025
|
| View |
|
DR-XY31278
|
Multivitamins +Minerals
|
Vigor-Ace
|
see reverse for formulation
|
Softgel Capsule
|
Over-The-Counter (OTC) Drug
|
HDPE Bottle of 30's and 75's (box of 1's)
|
-
|
PT Darya-Varia Laboratoria TBK
|
Indonesia
|
|
UNILAB, Inc.
|
|
-
|
18 September 2020
|
24 November 2025
|
| View |
|
DR-XY31283
|
Hyoscyamine Sulfate + Atropine Sulfate + Hyoscine Hydrobromide
|
Donnatab (for Export Only)
|
103.7mcg/ 19.4mcg/ 6.5mcg
|
Tablet
|
Prescription Drug (Rx)
|
Blister Pack x 25's (Box of 25's and 50's)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Wyeth Consumer Healthcare Pty. Ltd.
|
|
|
Automatic Renewal
|
19 October 2022
|
24 November 2025
|
| View |
|
DR-XY31295
|
Ciclesonide
|
Alvesco
|
160 mcg per actuation
|
Solution for Inhalation (Metered Dose Inhaler)
|
Prescription Drug (RX)
|
Aluminum Canister X 60 and 120
(Box of 1’s)
|
Glucocorticoid
|
3M Health Care Limited
|
United Kingdom
|
AstraZeneca AB
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
N/A
|
Initial (from Monitored Release)
|
31 May 2022
|
30 November 2024
|
| View |
|
DR-XY31296
|
Ciclesonide
|
Alvesco
|
80 mcg per actuation
|
Solution for Inhalation (Metered Dose Inhaler)
|
Prescription Drug (RX)
|
Aluminum Canister X 60 and 120
(Box of 1’s)
|
Glucocorticoid
|
3M Health Care Limited
|
United Kingdom
|
AstraZeneca AB
|
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
N/A
|
Initial (from Monitored Release)
|
31 May 2022
|
30 November 2024
|
| View |
|
DR-XY31298
|
Montelukast
|
Kastair EZTab
|
4 mg
|
Tablet
|
Prescription Drug (Rx)
|
Aluminum Foil Strip x 4's Box of 28's
|
Leukotriene Receptor Antagonist
|
Amherst Laboratories, Inc.
|
Philippines
|
UNILAB, Inc.
|
N/A
|
N/A
|
Renewal
|
19 August 2022
|
06 August 2027
|
| View |
|
DR-XY31312
|
Clindamycin (As Phosphate) + Benzoyl Peroxide
|
Duac
|
1% / 5%
|
Gel
|
Prescription Drug (RX)
|
Tube x 5 g, 15 g & 25 g
|
-
|
Glaxo Operations UK Ltd Trading
(as Glaxo Wellcome Operations)
|
United Kingdom
|
GlaxoSmithKline Philippines, Inc.
|
|
|
-
|
01 December 2020
|
06 December 2025
|
| View |
|
DR-XY31313
|
Clarithromycin
|
Clariget
|
125mg/5ml
|
Granules For Suspension
|
Prescription Drug (RX)
|
HDPE Plastic Bottle x 25mL, 50mL and 70mL
|
-
|
Getz Pharma (Pvt.) Ltd.
|
Pakistan
|
|
Getz Pharma (Phils.), Inc.
|
|
-
|
02 December 2020
|
06 December 2025
|
| View |
DR-XY31326_PI_01.pdf
|
DR-XY31326
|
Prednisolone Phosphate (As Sodium)
|
Romamed
|
20 mg/5 mL
|
Syrup
|
Prescription Drug (RX)
|
Boston Round Amber Bottle x 30 mL
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Medlink Pharma Phils., Inc.
|
|
|
-
|
04 December 2020
|
07 December 2025
|
| View |
|
DR-XY31328
|
Cetirizine Dihydrochloride
|
Alnix
|
2.5 mg/mL
|
Syrup (Oral Drops) - Grape Flavor
|
Over-the-Counter (OTC)
|
Amber Glass Bottle x 10 mL (Box of 1's)
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Unilab, Inc.
|
|
|
-
|
01 April 2020
|
06 April 2025
|
| View |
|
DR-XY31329
|
Cetirizine Dihydrochloride
|
Alnix
|
5 mg / 5 mL
|
Syrup
|
Over-the-Counter (OTC)
|
Amber Glass Bottle x 30mL and 60mL (Box of 1's)
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
-
|
13 April 2020
|
12 July 2025
|
| View |
|
DR-XY31333
|
Aspirin
|
Asplate
|
80 mg
|
Enteric-Coated Tablet
|
Prescription Drug (RX)
|
Foil Strip x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vitalink Health Products, Inc.
|
|
|
-
|
17 February 2021
|
08 December 2025
|
| View |
|
DR-XY31336
|
Cotrimoxazolë
|
Globaxol
|
400 mg/80 mg per 5 mL
|
Forte Suspension
|
Prescription Drug (RX)
|
Boston Round Amber Glass Bottle with 10 mL Plastic
Measuring Cup x 60 mL (Box of l’s)
|
-
|
Hizon Laboratories, Inc.
|
Philippines
|
GX International, Inc.
|
|
|
Initial (Variation)
|
05 August 2022
|
09 December 2025
|