| View |
|
DRP-9170-04
|
Budesonide
|
Bronchonide
|
250 mcg/mL (500 mcg/2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminum pouch (Box of 25's)
|
-
|
Legency Remedies Pvt. Ltd
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Euro-Care Products Philippines
|
CLIDP Conversion
|
23 July 2023
|
22 September 2025
|
| View |
|
DRP-9170-05
|
Budesonide
|
Broncort
|
250 mcg/mL (500 mcg/2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminum pouch (Box of 25's)
|
Glucocorticoid
|
Legency Remedies Pvt. Ltd
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
31 December 2023
|
22 September 2025
|
| View |
|
DRP-9170-06
|
Budesonide
|
Retaflow
|
250 mcg / mL (500 mcg / 2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminium pouch / (Box of 25's)
|
Glucocorticoid
|
Legency Remedies Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals Inc.
|
Reta Drug
|
CLIDP Conversion
|
12 July 2024
|
22 September 2025
|
| View |
|
DRP-9171
|
Telmisartan + Amlodipine (As Besilate)
|
Tamilopin-40
|
40 mg / 5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-Alu blister pack x 10'sby (Box of 30's)
|
-
|
KOLMAR KOREA CO., LTD.
|
Korea
|
|
Bellus Life Solution, Inc.
|
Bellus Life Solution, Inc.
|
-
|
25 September 2020
|
25 September 2025
|
| View |
|
DRP-9171-01
|
Telmisartan + Amlodipine (Besilate)
|
TEL-AMLO 40
|
40 mg/5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s (Box of 30’s)
|
ANGIOTENSIN II RECEPTOR BLOCKER/ CALCIUM CHANNEL BLOCKER
|
Genuone Sciences Inc
|
Korea
|
N/A
|
Bellus Life Solutions, Inc.
|
Aglobal Care, Inc
|
-
|
21 March 2022
|
25 September 2025
|
| View |
|
DRP-9171-02
|
Telmisartan + Amlodipine (as besilate)
|
Teldipin-40
|
40 mg/5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Genuone Sciences Inc
|
Korea
|
N/A
|
Bellus Life Solutions, Inc.
|
Macropharma Corporation
|
CLIDP Conversion
|
10 March 2023
|
25 September 2025
|
| View |
|
DRP-9172
|
Telmisartan + Amlodipine (As Besilate)
|
Tamilopin-80
|
80 mg / 5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack x 10's (box of 30's)
|
-
|
KOLMAR KOREA CO., LTD.
|
Korea
|
|
Bellus Life Solution, Inc.
|
Bellus Life Solution, Inc.
|
-
|
25 September 2020
|
25 September 2025
|
| View |
|
DRP-9172-01
|
Telmisartan + Amlodipine (Besilate)
|
Tel-Amlo 80
|
80 mg/5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s (Box of 30’s)
|
ANGIOTENSIN II RECEPTOR BLOCKER/ CALCIUM CHANNEL BLOCKER
|
Genuone Sciences Inc.
|
Korea
|
N/A
|
Bellus Life Solutions, Inc.
|
Aglobal Care, Inc.
|
-
|
24 March 2022
|
25 September 2025
|
| View |
|
DRP-9172-02
|
Telmisartan + Amlodipine (as besilate)
|
Teldipin-80
|
80 mg/5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Genuone Sciences Inc
|
Korea
|
N/A
|
Bellus Life Solutions, Inc
|
Macropharma Corporation
|
CLIDP Conversion
|
28 February 2023
|
25 September 2025
|
| View |
|
DRP-9173
|
Bortezomib
|
Kemizob
|
3.5 mg
|
Lyophilized Powder For Solution For Injection (I.V./S.C.)
|
Prescription Drug (Rx)
|
Eu.ph. Type I clear glass vial stoppered with 20 mm grey butyl rubber stopper with aluminum seal and red flip-off cap (box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Aglobal Care, inc.
|
Aglobal Care, inc.
|
-
|
25 September 2020
|
25 September 2025
|
| View |
|
DRP-9173-1
|
Bortezomib
|
Delexomib
|
3.5 mg
|
Lyophilized Powder for Injection (S.C./I.V.)
|
Prescription Drug (Rx)
|
Eu. Ph. Type I clear glass vial stoppered with 20 mm grey butyl rubber stopper, sealed with aluminum seal and red flip-off cap (Box of 1's)
|
Antineoplastic Agent (Proteasome Inhibitor)
|
Venus Remedies Ltd
|
India
|
|
Aglobal Care, Inc
|
Delex Pharma International, Inc.
|
CLIDP Conversion
|
19 May 2023
|
25 September 2025
|
| View |
|
DRP-9174
|
Parecoxib (as sodium)
|
Sancox
|
40 mg
|
Lyophilized Powder For Injection (IM/IV)
|
Prescription Drug (Rx)
|
5 mL USP Type I Flint Glass Tubular Vuial + 2 mL Clear Glass Ampoule as diluent in a box
|
-
|
Gufic Biosciences Ltd.
|
India
|
|
SRS Pharmaceuticals Phils. Inc.
|
RX Global Sales aand Marketing Corp.
|
PCPR
|
25 September 2020
|
02 October 2025
|
| View |
|
DRP-9174-01
|
Parecoxib (As sodium)
|
Relifast
|
40 mg
|
Lyophilized Powder For Injection (IM/IV)
|
Prescription Drug (RX)
|
5 ML USP TYPE I FLINT GLASS TUBULAR VIAL + 2ML CLEAR GLASS AMPOULE AS DILUENT IN A BOX
|
-
|
Gufic Biosciences
|
India
|
|
SRS Pharmaceuticals Phils Inc
|
The Cathay Drug Co., Inc.
|
Initial
|
06 August 2021
|
02 October 2025
|
| View |
|
DRP-9175
|
Ascorbic Acid + Zinc (As Sulfate Monohydrate)
|
Hav C Plus
|
600 mg/ 137.25 mg (equivalent to 50 mg elemental Zinc)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/ Deep Red PVC Blister Pack x 10's (Box of 30's, 60's, 90's, and 100's)
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
St. Raphael The Archangel Pharmaceutical Distributor, Inc.
|
|
|
-
|
25 September 2020
|
25 September 2025
|
| View |
|
DRP-9176
|
Budesonide
|
Budecton
|
200 mcg
|
Dry Powder in Capsule for Oral Inhalation
|
Prescription Drug (Rx)
|
Alu/PVC/PVDC Blister Pack x 10's (Box of 60's)
|
-
|
World Medicine Ilac Sanayi Ve Tiracet A.S.
|
Turkey
|
|
Pharma-surrey International,Inc.
|
Pharma-surrey International,Inc.
|
-
|
28 September 2020
|
28 September 2025
|
| View |
|
DRP-9177
|
Ceftazidime (as Pentahydrate)
|
Ceftazim
|
1g
|
Powder for Injection (IM/IV)
|
Prescription Drug (Rx)
|
KP clear glass vials, stoppered with gray color butyl rubber stoppers and sealed with blue color aluminum cap (Box of 10's)
|
-
|
Kukje Pharm Ind. Co., Ltd.
|
Korea
|
|
H & B Pharma International Inc.
|
H & B Pharma International Inc.
|
-
|
28 September 2020
|
28 September 2025
|
| View |
|
DRP-9177-01
|
Ceftazidime (As Pentahydrate)
|
Armazidime
|
1 g
|
Powder For Injection (IV / IM)
|
Prescription Drug (RX)
|
KP Clear Glass Vial with Gray Color Butyl Rubber
Stopper and Sealed with Blue Color Aluminum Cap (Box of 10's)
|
-
|
Kukje Pharma Co., Ltd.
|
Korea
|
|
H & B International Inc.
|
Pharmaessence Inc.
|
-
|
17 September 2021
|
28 September 2025
|
| View |
|
DRP-9178
|
Paracetamol + Guaifenesin + Phenylpropanolamine HCl + Dextromethorphan HBr + Chlorphenamine maleate
|
Paratuss
|
325 mg/50 mg/30 mg/15 mg/1 mg
|
Capsule
|
Over-the-Counter (OTC)
|
Alu Foil Strip Pack x 10's (Box of 100's)
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
N/A
|
N/A
|
N/A
|
Initial [OTC] [Revalidation]
|
04 August 2023
|
28 September 2025
|
| View |
|
DRP-9178-02
|
Paracetamol + Guaifenesin + Phenylpropanolamine HCl + Dextromethorphan HBr + Chlorphenamine maleate
|
Maxituss
|
325 mg/50 mg/30 mg/15 mg/1 mg
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu Foil Strip Pack x 10's (Box of 100's)
|
Analgesic/Expectorant/Nasal Decongestant/Antitussive/Antihistamine
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
Cassandras Care Pharmaceutical Distributor
|
CLIDP Conversion
|
13 October 2023
|
28 September 2025
|
| View |
|
DRP-9178-03
|
Paracetamol + Guaifenesin + Phenylpropanolamine HCl + Dextromethorphan HBr + Chlorphenamine Maleate
|
Tuceedcap
|
325 mg/50 mg/30 mg/15 mg/1 mg
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu Foil Strip Pack x 10's (Box of 100's)
|
Analgesic/Expectorant/Nasal Decongestant/Antitussive/Antihistamine
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
CDMED Pharmaceutical And Medical Supply
|
CLIDP Conversion
|
31 December 2023
|
28 September 2025
|