View |
|
DRP-9140
|
Calcium
|
Ambical
|
500 mg (equivalent to 1.25g Calcium Carbonate)
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu-PVC/PVDC Blister Pack x 10's (Box of 30's and
100's)
|
Mineral
|
Jiangxi Xierkangtai Pharmaceutical Co., Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial [OTC][Revalidation][Correction]
|
17 May 2024
|
14 September 2025
|
View |
|
DRP-9140-01
|
Calcium
|
Calcilife
|
500 mg (equivalent to 1.25 g Calcium Carbonate)
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu-PVC/PVDC Blister Pack x 10's / (Box of 30's and 100's)
|
Mineral
|
Jiangxi Xierkangtai Pharmaceutical Co., Ltd
|
China
|
|
AMB HK Enterprises Inc
|
Life and Health Source Pharmaceutical Distribution Co.
|
CLIDP Conversion
|
12 June 2024
|
14 September 2025
|
View |
|
DRP-9143
|
Cefazolin (As Sodium)
|
Maxolin
|
1 g
|
Powder for Injection (IM/IV)
|
Prescription Drug (RX)
|
10-mL capacity clear borosilicate glass vial with
halogenated butyl rubber stopper and aluminum plastic cap (Box of 10's)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
03 November 2020
|
03 November 2025
|
View |
|
DRP-9144
|
Ceftriaxone (as sodium)
|
Zeptriagem
|
1g
|
Powder for Injection (IM/IV)
|
Prescription Drug (RX)
|
10 mL-capacity Type III soda lime glass vial with
butyl rubber stopper and aluminium plastic cap + USP Type I borosilicate glass ampoule x 10 ml water for injection as diluent (Box of l's)
|
-
|
Ncpc Hebei Huamin Pharmaceutical Co., Ltd.
|
China
|
|
Euro-Care Products Philippines
|
Euro-Care Products Philippines
|
Initial (Variation)
|
07 December 2022
|
03 November 2025
|
View |
|
DRP-9144-01
|
Ceftriaxone (as sodium)
|
Zeptriavee
|
1 g
|
Powder for Injection (IM/IV)
|
Prescription Drug (Rx)
|
10 mL-capacity Type III soda lime glass vial with butyl rubber stopper and aluminium plastic cap + USP Type I Borosilicate Glass Ampoule x 10 mL Water for Injection as Diluent (Box of 1's)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
N/A
|
Euro-Care Products Philippines
|
Asianmeds, Inc.
|
CLIDP Conversion
|
26 April 2023
|
03 November 2025
|
View |
|
DRP-9146
|
Salbutamol (as Sulfate)
|
Astholax
|
100 mcg/actuation
|
Pressurized Metered Dose Inhaler
|
Prescription Drug (RX)
|
Aluminum canister x 200 doses (Box of 1's)
|
-
|
Medisol Lifesciences Pvt Ltd
|
India
|
|
Srs Pharmaceuticals Phils Inc
|
Srs Pharmaceuticals Phils Inc
|
-
|
03 November 2020
|
03 November 2025
|
View |
|
DRP-9148
|
Doxorubicin Hydrochloride
|
Oxoru-10
|
2 mg/mL (10 mg/5 mL)
|
Solution For Injection (I.V.)
|
Prescription Drug (RX)
|
USP Type I Amber-colored tubular glass vial sealed with 20 mm grey bromo butyl rubber plug, aluminum seal, and 20 mm red flip off cap x 5mL (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
-
|
18 September 2020
|
18 September 2025
|
View |
|
DRP-9148-01
|
Doxorubicin hydrochloride
|
D-Xobin 10
|
2 mg/mL (10 mg/5 mL)
|
Solution for Injection (I.V.)
|
Prescription Drug (Rx)
|
USP Type I amber-colored tubular glass vial sealed with 20 mm grey bromo butyl rubber plug, aluminum seal, and 20 mm red flip off cap x 5 mL (Box of 1's)
|
ANTINEOPLASTIC AGENT (ANTHRACYCLINE)
|
Venus Remedies Ltd
|
India
|
N/A
|
Aglobal Care, Inc
|
Bellus Life Solutions, Inc
|
-
|
02 June 2022
|
18 September 2025
|
View |
|
DRP-9149
|
Bortezomib
|
None
|
3.5 mg
|
Lyophilized Powder For Injection (I.V./S.C.)
|
Prescription Drug (Rx)
|
USP Type I clear glass vial with 13 mm grey chlorobutyl rubber stopper and aluminum seal with 13 mm royal blue polypropylene flip-off cap (Box of 1's)
|
-
|
|
|
|
|
|
Initial (Variation)
|
15 November 2022
|
18 September 2025
|
View |
|
DRP-9151
|
Warfarin sodium
|
WAFRIN-5
|
5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack by 10's (Box of 30's)
|
-
|
CELOGEN GENERICS PVT. LTD.
|
India
|
|
Aglobal Care, inc.
|
Aglobal Care, inc.
|
-
|
18 September 2020
|
18 September 2025
|
View |
|
DRP-9152
|
Warfarin sodium
|
WAFRIN-2.5
|
2.5 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack by 10's (Box of 30's)
|
-
|
CELOGEN GENERICS PVT. LTD.
|
India
|
|
Aglobal Care, inc.
|
Aglobal Care, inc.
|
-
|
18 September 2020
|
18 September 2025
|
View |
|
DRP-9153
|
Warfarin sodium
|
WAFRIN-1
|
1 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack by 10's (Box of 30's)
|
-
|
CELOGEN GENERICS PVT. LTD.
|
India
|
|
Aglobal Care, inc.
|
Aglobal Care, inc.
|
-
|
18 September 2020
|
18 September 2025
|
View |
|
DRP-9154
|
Diosmin + Hesperidin
|
Dh-Hemorix
|
450 mg / 50 mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
PT. PHAPROS TBK
|
Indonesia
|
|
Bellus Life Solutions, Inc.
|
|
-
|
26 November 2020
|
26 November 2025
|
View |
|
DRP-9155
|
Diosmin + Hesperidin
|
Spivar
|
450mg/50mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial[OTC][PCPR]
|
20 May 2021
|
20 May 2026
|
View |
|
DRP-9156
|
Diosmin + Hesperidin
|
D-Hesper
|
450mg/50mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial[OTC][PCPR]
|
20 May 2021
|
20 May 2026
|
View |
|
DRP-9156-01
|
Diosmin + Hesperidin
|
None
|
450 mg/50 mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's Box of 100's
|
Vasoprotective
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
-
|
15 October 2021
|
20 May 2026
|
View |
|
DRP-9156-02
|
Diosmin + Hesperidin
|
None
|
450 mg/50 mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100’s)
|
Vasoprotective
|
Stallion Laboratories Pvt. Ltd
|
India
|
N/A
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
-
|
12 May 2022
|
20 May 2026
|
View |
|
DRP-9157
|
Diosmin + Hesperidin
|
Diosid
|
450mg/50mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial[OTC][PCPR]
|
20 May 2021
|
20 May 2026
|
View |
|
DRP-9158
|
Diosmin + Hesperidin
|
Venacure
|
450mg/50mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial[OTC][PCPR]
|
20 May 2021
|
20 May 2026
|
View |
|
DRP-9159
|
Diosmin + Hesperidin
|
Ioper
|
450mg/50mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial[OTC][PCPR]
|
20 May 2021
|
20 May 2026
|