| View |
|
DRP-8747-03
|
Omeprazole (as sodium)
|
Promezol
|
40 mg
|
Lyophilized Powder for Intravenous Injection / Infusion
|
Prescription Drug (Rx)
|
USP Type I Tubular Glass vial with Butyl Rubber Stopper and Flip-off Cap / (Box of 10's)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
|
Sanimed Pharmaceuticals Inc
|
Hillcross Prime, Inc.
|
CLIDP Conversion
|
30 May 2024
|
21 February 2025
|
| View |
DRP-8748_PI_01.pdf
|
DRP-8748
|
Oxytocin
|
Evexy
|
10 IU/mL
|
Solution For Injection (IM/IV Infusion)
|
Prescription Drug (RX)
|
Type 1 Hydrolytic Resistant Class
Colourless Borosilicate Glass Ampoules x 1mL (net content). Box of 10's.
|
Posterior Pituitary Lobe Hormone
|
HBM Pharma S.R.O.
|
Slovak Republic
|
|
Ambica International Trading Corporation
|
Ambica International Trading Corporation
|
Renewal
|
08 May 2024
|
21 February 2030
|
| View |
|
DRP-8749
|
Clindamycin (as Phosphate)
|
Euromycin 600
|
150mg/Ml (600mg/4 Ml)
|
Solution for Injection (I.M/I.V.)
|
Prescription Drug (Rx)
|
Type I Clear, colorless glass vial x 4mL (net content) (Box of 1's)
|
-
|
Vesco Pharmaceutical Company Limited
|
Thailand
|
|
Euro-Care Products Philippines
|
Euro-Care Products Philippines
|
-
|
21 February 2020
|
21 February 2025
|
| View |
|
DRP-8749-01
|
Clindamycin (As Phosphate)
|
Clindavest 600
|
150mg/mL(600mg/4mL)
|
Solution For Injection (IM/IV)
|
Prescription Drug (RX)
|
Type I Clear, Colorless Glass Vial x 4 mL (net
content). Box of 1's.
|
-
|
Vesco Pharmaceutical Company Limited
|
Thailand
|
N/A
|
Euro-Care Products, Phils.
|
Asianmeds, Inc.
|
Initial (Variation)
|
18 August 2023
|
21 February 2025
|
| View |
|
DRP-8749-02
|
Clindamycin (as Phosphate)
|
Marzyn 600
|
150 mg/ mL (600 mg/4 mL)
|
Solution for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
Type I clear, colorless glass vial x 4 mL (net content) (Box of 1's)
|
-
|
Vesco Pharmaceutical Company Limited
|
Thailand
|
N/A
|
Euro-Care Products Philippines
|
MDB Pharma Trading
|
CLIDP Conversion
|
15 May 2023
|
21 February 2025
|
| View |
|
DRP-8750
|
Pregabalin
|
Convult
|
75mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu/PVC blister pack x 10's (Box of 10's)
|
Anti-epileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
25 March 2024
|
21 February 2030
|
| View |
|
DRP-8750-01
|
Pregabalin
|
Pregabur
|
75 mg
|
Capsule
|
Prescription Drug (RX)
|
Alu/PVDC Blister Pack x 10's (Box of 10's)
|
Anti-epileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Corbridge Group Phils., Inc.
|
Initial (Compliance)
|
04 May 2022
|
21 February 2025
|
| View |
|
DRP-8751
|
Methylprednisolone (As Sodium Succinate)
|
Biprosolone-500
|
500 mg
|
Powder For Solution For Injection (Im/Iv)
|
Prescription Drug (RX)
|
USP Type I 10mL Glass Vial with 20mm Bromobutyl Rubber Closure and Aluminum Flip-Off Seal (Box of 1's)
|
Corticosteroids
|
Swiss Parenterals Pvt. Ltd.
|
India
|
|
Ambicare Pharmaceuticals Inc.
|
Ambicare Pharmaceuticals Inc.
|
Automatic Renewal
|
14 September 2022
|
04 January 2028
|
| View |
|
DRP-8751-01
|
Methylprednisolone (as Sodium Succinate)
|
Methyxale - 500
|
500 mg
|
Powder for Solution for Injection (IM/IV)
|
Prescription Drug (Rx)
|
USP Type I 10 mL Glass Vial with 20 mm Bromobutyl Rubber Closure and Aluminum Flip-Off Seal (Box of 1's)
|
-
|
Swiss Parenterals Pvt. Ltd.
|
India
|
N/A
|
Ambicare Pharmaceuticals Inc.
|
Uni-Pharma Phils., Inc
|
CLIDP Conversion
|
31 January 2023
|
04 January 2028
|
| View |
|
DRP-8752
|
Clomifene Citrate
|
Fertab-50
|
50 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVC Blister Pack x 10's (Box of 10's)
|
Ovulation Stimulant
|
Oman Pharmaceutical Products Co. L.L.C.
|
Oman
|
|
Atlantic Pharmaceuticals, Inc.
|
Embil International Philippines, Inc.
|
Renewal
|
30 June 2024
|
30 July 2029
|
| View |
|
DRP-8753
|
Vinorelbine (as tartrate)
|
EBERELBIN
|
10mg/ mL
|
Concentrate Solution For Iv Infusion
|
Prescription Drug (Rx)
|
In 2mL-USP Type I Clear Glass Vial with grey rubber stopper and Aluminum crimp cap x 1mL (Box of 1's)
|
-
|
Ebewe Pharma Ges.m.b.H. Nfg. KG
|
Austria
|
|
Sandoz Philippines Corporation
|
|
-
|
11 March 2020
|
11 March 2025
|
| View |
|
DRP-8754
|
Adapalene
|
Dipalen
|
1 mg/g (0.1%)
|
Topical Gel
|
Prescription Drug (RX)
|
PE Tube with White cap (Box of 1 x 15g; Box of 1 x 30g)
|
-
|
Kolmar Korea Co., Ltd.
|
Korea
|
|
H&B Pharma International Inc.
|
H&B Pharma International Inc.
|
-
|
11 March 2020
|
11 March 2025
|
| View |
|
DRP-8754-01
|
Adapalene
|
Adapasenz
|
1 mg/g (0.1%)
|
Topical Gel
|
Prescription Drug (RX)
|
PE tube with white cap (Box of 1 x 15 g; Box of 1 x 30
|
-
|
Kolmar Korea Co., Ltd.
|
Korea
|
|
H & B Pharma International Inc.
|
Pharma essence Inc.
|
-
|
16 November 2021
|
11 March 2025
|
| View |
DRP-8755_PI_01.pdf
|
DRP-8755
|
Bromhexine Hydrochloride
|
Bromucol
|
4mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
Boston Round Glass Amber Bottle x 60mL and 120mL with Aluminum Pilfer Proof Cap and Foam Polyethylene Liner (Box of 1's)
|
-
|
San Marino Laboratories Corp.
|
Philippines
|
|
|
|
-
|
13 March 2020
|
13 March 2025
|
| View |
DRP-8756_PIL_01.pdf
|
DRP-8756
|
Diphenhydramine Hydrochloride
|
Carantin
|
12.5mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
Boston Round Glass Amber Bottle x 60mL with Aluminum Pilfer Proof Cap and Foam Polyethylene Liner (Box of 1's)
|
-
|
San Marino Laboratories Corp.
|
Philippines
|
|
|
|
-
|
13 March 2020
|
13 March 2025
|
| View |
|
DRP-8757
|
Donepezil hydrochloride
|
None
|
5mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/PVC/PVDC blister pack x 10's (Box of 30's)
|
-
|
Whan In Pharm. Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
JLT Pharma, Inc.
|
-
|
11 March 2020
|
11 March 2025
|
| View |
DRP-8757-01_PI_01.pdf
|
DRP-8757-01
|
Donepezil Hydrochloride
|
Donepedin
|
5 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC/PVDC Blister pack x 10's (Box of 30's)
|
-
|
Whan In Pharm Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
Medchoice CNS Pharma Corporation
|
Initial
|
06 August 2021
|
11 March 2025
|
| View |
|
DRP-8758
|
Donepezil hydrochloride
|
None
|
10mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/PVC/PVDC blister pack x 10's (Box of 30's)
|
-
|
Whan In Pharm. Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
JLT Pharma, Inc.
|
-
|
11 March 2020
|
11 March 2025
|
| View |
DRP-8758-01_PI_01.pdf
|
DRP-8758-01
|
Donepezil Hydrochloride
|
Donepedin
|
10mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC/PVDC Blister pack x 10's (Box of 30's)
|
-
|
Whan In Pharm Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
Medchoice CNS Pharma Corporation
|
Initial
|
10 August 2021
|
11 March 2025
|
| View |
|
DRP-8759
|
Metronidazole
|
Metrynal
|
5mg/mL (500mg/100mL)
|
Solution For Injection (Iv Infusion)
|
Prescription Drug (RX)
|
USP Type II colorless and transparent glass bottle with bromubutyl rubber closure and aluminum cap x 100ml (net content). Box of 10's
|
-
|
Dai Han Pharm. Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
JLT Pharma, Inc.
|
-
|
11 March 2020
|
11 March 2025
|