| View |
|
DRP-9478-01
|
Rosuvastatin (as calcium)
|
Zyrova
|
40 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt. Ltd
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc
|
Zydus Healthcare Philippines Inc
|
CLIDP Conversion
|
29 October 2022
|
25 October 2026
|
| View |
|
DRP-9478-02
|
Rosuvastatin (as calcium)
|
Rosubet-40
|
40 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt. Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Better Option Pharmaceuticals, Inc
|
CLIDP Conversion
|
20 January 2024
|
25 October 2026
|
| View |
|
DRP-9479
|
Telmisartan + Hydrochlorothiazide
|
Teluvis Plus
|
80 mg/25 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Sandoz Grup Saglik Ürünleri Ilaclari San. Ve. Tic.
A.S
|
Turkey
|
|
Sandoz Philippines Corporation
|
Sandoz Philippines Corporation
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-948
|
Clopidogrel (As Bisulfate)
|
Plagerine
|
75 mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister pack
|
Antithrombotic ( Antiplatelet )
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Automatic Renewal
|
28 September 2022
|
07 January 2028
|
| View |
|
DRP-948-01
|
Clopidogrel
|
Vivelon
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10s
|
Antithrombotic
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Xeno Pharmaceutical Phils. Inc.
|
Automatic Renewal
|
23 December 2022
|
07 January 2028
|
| View |
|
DRP-9480
|
Diclofenac sodium
|
Novafenac
|
25 mg/mL
|
Solution for Injection (I.M./I.V.)
|
Prescription Drug (RX)
|
3 mL clear, colorless Type I glass ampoule (Box of 5's)
|
-
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
|
Medinova Pharmaceutical Inc.
|
Medinova Pharmaceutical Inc.
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9481
|
Bortezomib
|
Zortomib
|
3.5 mg
|
Lyophilized Powder For Injection (IV/SC)
|
Prescription Drug (RX)
|
10 mL clear, moulded, Type I glass vial with
bromobutyl rubber stopper, aluminum flip-off seal and
green polypropylene cap (Box of l's)
|
-
|
ADMAC Lifesciences
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
02 February 2021
|
02 February 2026
|
| View |
|
DRP-9482
|
Bortezomib
|
Uniborte-3.5
|
3.5mg
|
Lyophilized Powder for Solution for Injection
(I.V./S.C.
|
Prescription Drug (RX)
|
10 mL clear, moulded, Type I glass vial with
bromobutyl rubber stopper, aluminum flip-off seal and green polypropylene cap (Box of l's)
|
-
|
ADMAC Lifesciences
|
India
|
Unicare Health sciences Pvt. Ltd.
|
AGB Pharmaceutical Trading and Consultancy
Corporation
|
AGB Pharmaceutical Trading and Consultancy
Corporation
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9483
|
Hydrocortisone (as acetate)
|
Hydrosone
|
10 mg/g (1% w/w)
|
Cream
|
Prescription Drug (RX)
|
10 g Laminated plastic tube (Box of l's)
|
-
|
Blossom Pharmaceuticals
|
India
|
|
Wellchem Pharmaceutical Products
|
Wellchem Pharmaceutical Products
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9484
|
Clotrimazole
|
Clotizole
|
10 mg/g (1% w/w)
|
Cream
|
Prescription Drug (RX)
|
Aluminum collapsible tube x 10 g (Box of 1's);
Aluminum collapsible tube x 20 g (Box of 1's)
|
-
|
Blossom Pharmaceuticals
|
India
|
|
Wellchem Pharmaceutical Products
|
Wellchem Pharmaceutical Products
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9485
|
Clobetasol Propionate
|
Clobechem
|
500 mcg/g (0.05% w/w)
|
Cream
|
Prescription Drug (RX)
|
5 g, 15 g, and 30 g collapsible aluminum tubes (Box of l's)
|
-
|
Blossom Pharmaceuticals
|
India
|
|
Wellchem Pharmaceutical Products
|
Wellchem Pharmaceutical Products
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9486
|
Azithromycin (As Dihydrate)
|
Zithmac
|
500mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-PVC Blister Pack x 3's Box of 3's (Box of 1's)
|
-
|
Zim Laboratories Ltd
|
India
|
|
I.E. Medica Inc.
|
I.E. Medica Inc.
|
Initial
|
16 August 2021
|
16 August 2026
|
| View |
|
DRP-9487
|
Azithromycin (As Dihydrate)
|
Throx500
|
500mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-PVC Blister Pack x 3's (Box of 1's)
|
-
|
Zim Laboratories Limited
|
India
|
|
I.E. Medica, Inc.
|
MedEthix, Inc.
|
Initial
|
16 August 2021
|
16 August 2026
|
| View |
|
DRP-9488
|
Naproxen
|
None
|
275 mg
|
Film Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Film Clear Blister Pack x 10's (Box of 10's and 30's)
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
|
|
|
-
|
21 January 2021
|
21 January 2026
|
| View |
|
DRP-9489
|
Paracetamol + Phenylephrine + Chlorpheniramine Maleate+Caffeine Anhydrous
|
Nasalmed
|
500 mg/5 mg/2mg/15 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 4's (Box of 40's)
|
-
|
Saga Lifesciences Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Medinova Pharmaceutical Inc.
|
-
|
21 January 2021
|
21 January 2026
|
| View |
|
DRP-9489-01
|
Paracetamol + Phenylephrine Hydrochloride
Chlorphenamine Maleate + Caffeine Anhydrous
|
Sinucass
|
500 mg/5 mg/2 mg/15 mg
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/PVC Blister Pack x 4's (Box of 40's)
|
-
|
Saga Lifesciences Limited
|
India
|
N/A
|
Medinova Pharmaceutical Inc.
|
Cassandras Care Pharmaceutical Dsitributions
|
-
|
05 July 2021
|
21 January 2026
|
| View |
|
DRP-9489-02
|
Paracetamol + Phenylephrine Hydrochloride
Chlorphenamine Maleate + Caffeine Anhydrous
|
Nazogen
|
500 mg/5 mg/2 mg/15 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 4's (Box of 40's)
|
Analgesic/Antipyretic/Nasal
Decongestant/Antihistamine
|
Saga Lifesciences Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc.
|
Initial (OTC) (CLIDP)
|
19 July 2021
|
21 January 2026
|
| View |
|
DRP-9489-03
|
Paracetamol + Phenylephrine Hydrochloride +
Chlorphenamine Maleate + Caffeine Anhydrous
|
Plemasin
|
500 mg/5 mg/2 mg/15 mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 4's (Box of 40's)
|
-
|
Medinova Pharmaceutical Inc.
|
Philippines
|
|
Medinova Pharmaceutical Inc.
|
RM Lorenzo Pharma
& Distribution Inc.
|
-
|
19 October 2021
|
21 January 2026
|
| View |
|
DRP-9490
|
Amorolfine
|
Oflomil
|
50 mg/mL (5% w/v)
|
Topical Solution
|
Over-the-counter (OTC) Drug
|
Type I amber coloured glass bottle w/
opaque white, tamper-evident HDPE
closure
|
-
|
Glenmark Pharmaceuticals Ltd.
|
India
|
|
Glenmark Philippines, Inc.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9491
|
ASCORBIC ACID
|
FIN-CEE
|
500mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
VITAMIN
|
Mason Pharma
|
India
|
|
Finstad Inc.
|
|
Renewal
|
26 February 2024
|
25 January 2029
|