View |
|
DRP-8685
|
Cefotaxime(as sodium)
|
Cefolan
|
1 g
|
Powder For Injection (Im/Vi)
|
Prescription Drug (RX)
|
USP Type III Clear Glass Vial with Rubber Stopper and Yellow Flip-off Seal x 1g.( Box of 1's)
|
Antibacterial (Cephalosporin)
|
Zhuhai United Laboratories (Zhongshan) Co., Ltd.
|
China
|
|
Aglobal Care Inc.
|
Aglobal Care Inc.
|
Renewal
|
27 June 2022
|
19 July 2027
|
View |
|
DRP-8686
|
Cefotaxime (as sodium)
|
Sefox
|
1g
|
Powder For Injection (Im/Iv)
|
Prescription Drug (RX)
|
Type III Clear Colorless Glass Vial with grey butyl rubber stopper and sealed with blue flip-off aluminum cap (Box of 1's and 10's)
|
Antibacterial (Third Generation Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
Renewal
|
22 March 2023
|
18 May 2028
|
View |
|
DRP-8686-01
|
Cefotaxime (As Sodium)
|
Oxima
|
1 g
|
Powder Of Injection (Im/Iv)
|
Prescription Drug (RX)
|
Type III Clear Colorless Glass Vial with Grey Butyl Rubber Stopper and Sealed with Blue Flip-off Aluminum Cap (Box of 1's and 10's)
|
Antibacterial (Third Generation Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
|
Aglobal Care, Inc.
|
Bellus Life Solutions, Inc.
|
Renewal
|
06 June 2023
|
18 May 2028
|
View |
|
DRP-8687
|
Tranexamic Acid
|
Glotrek
|
100 mg/mL (500 mg/5mL)
|
Solution For Injection (Iv)
|
Prescription Drug (RX)
|
Type I Clear Colorless Glass Ampoule x 5 mL (net content) in plastic tray (Box of 5's)
|
Antifibrinolytic
|
Unijules Life Sciences Limited
|
India
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
Renewal
|
01 March 2024
|
20 May 2029
|
View |
|
DRP-8687-01
|
Tranexamic Acid
|
Anexa
|
100 mg/mL (500 mg/5 mL)
|
Solution For Injection (IV)
|
Prescription Drug (RX)
|
Type I Clear Colorless Glass Ampoule x 5 mL (as net Content) in Plastic Tray (Box of 5's)
|
Antifibrinolytic
|
Unijules Life Sciences Limited
|
India
|
|
Aglobal Care, Inc.
|
Bellus Life Solutions, Inc.
|
Renewal
|
16 May 2024
|
20 May 2029
|
View |
|
DRP-8687-02
|
Tranexamic Acid
|
Hemotrex
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (IV)
|
Prescription Drug (RX)
|
Type I Clear Colorless Glass Ampoule x 5 mL (Net
Content) in Plastic Tray (Box of 5's)
|
Antifibrinolytic
|
Unijules Life Science Limited
|
India
|
|
Aglobal Care, Inc.
|
Nutramedica Inc.
|
Renewal
|
22 May 2024
|
20 May 2029
|
View |
|
DRP-8687-03
|
Tranexamic Acid
|
Kexamic
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (IV)
|
Prescription Drug (Rx)
|
Type I Clear Colorless Glass Ampoule x 5 mL (Net Content) in Plastic Tray (Box of 5's)
|
ANTIFIBRINOLYTIC
|
Unijules Life Sciences Linited
|
India
|
N/A
|
Aglobal Care, Inc.
|
Pharma King Distributor
|
Renewal
|
19 June 2024
|
20 May 2029
|
View |
|
DRP-8687-04
|
Tranexamic Acid
|
Hemocare
|
100 mg/ mL (500 mg/ 5 mL)
|
Solution for Injection (IV)
|
Prescription Drug (Rx)
|
Type I Clear Colorless Glass Ampoule x 5 mL (Net Content) in Plastic Tray (Box of 5's)
|
Antifibrinolytic
|
Unijules Life Sciences Limited
|
India
|
N/A
|
Aglobal Care, Inc
|
Euro-Care Products Philippines
|
Renewal
|
10 June 2024
|
20 May 2029
|
View |
|
DRP-869
|
Ranitidine (as Hydrochloride)
|
Aciloc
|
25mg/mL
|
Solution for Injection (IM/IV)
|
Prescription Drug (RX)
|
USP Type I Glass Ampoule in Blister Pack x 2mL (Box of 5's)
|
H2 Receptor Antagonist
|
Cadila Pharmaceutical Limited
|
India
|
|
Ambica International Crop.
|
Speed Cure Pharma
|
Renewal
|
26 April 2019
|
12 March 2029
|
View |
|
DRP-869-01
|
Ranitidine (as Hydrochloride)
|
Eastidine
|
25 mg/mL
|
Solution for Injection (IM/IV)
|
Prescription Drug (Rx)
|
USP Type I Glass Ampoule in Blister Pack x 2 mL (Box of 5's)
|
H2 Receptor Antagonist
|
Cadila Pharmaceuticals Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc
|
Renewal
|
05 October 2023
|
12 March 2029
|
View |
|
DRP-869-02
|
Ranitidine (as Hydrochloride)
|
Hacidac
|
25 mg/mL
|
Solution For Injection (Im/Iv)
|
Prescription Drug (RX)
|
USP Type I Glass Ampoule x 2mL in Blister Pack x 5's (Box of 5's)
|
H2 Receptor Antagonist
|
Cadila Pharmaceutical Limited
|
India
|
|
Ambica International Trading Corp.
|
Altomed Pharmaceuticals, Inc.
|
Renewal
|
31 October 2023
|
12 March 2029
|
View |
|
DRP-869-03
|
Ranitidine (as Hydrochloride)
|
Loracid
|
25 mg/mL
|
Solution For Injection (IM/IV)
|
Prescription Drug (RX)
|
USP Type I Glass Ampoule in Blister Pack x 2 mL
(Box of 5's)
|
H2 Receptor Antagonist
|
Cadila Pharmaceuticals Ltd.
|
India
|
|
Ambica International Corporation
|
D&G Pharma
|
Renewal
|
31 October 2023
|
12 March 2029
|
View |
|
DRP-8691
|
Quetiapine (as fumarate)
|
Serotia 200
|
200 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/PVC Blister Pack x 10's (Box of 30's)
|
Antipsychotic
|
Sun Pharma Laboratories Ltd.
|
India
|
N/A
|
Sun Pharma Philippines, Inc.
|
Sun Pharma Philippines, Inc.
|
Initial (Variation) (Correction)
|
18 April 2024
|
27 June 2027
|
View |
|
DRP-8692
|
Risperidone
|
Sizodon 2
|
2 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/ Alu Foil Strip x 10's (Box of 50's)
|
-
|
Sun Pharmaceutical Industries Ltd.
|
India
|
|
Sun Pharma Philippines, Inc.
|
Sun Pharma Philippines, Inc.
|
-
|
19 February 2021
|
26 April 2026
|
View |
|
DRP-8693
|
Loratadine
|
Loragy
|
10mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu-PVC Blister Pack x 10's (Box of 100's)
|
Antihistamine
|
Lloyd Laboratores, Inc.
|
Philippines
|
Gold Life Distribution Phils., Inc.
|
|
|
Automatic Renewal
|
18 August 2021
|
29 September 2026
|
View |
|
DRP-8694
|
dl-Alpha-Tocopherol
Acetate (Vitamin E)
|
Luming-E 400
|
400 IU
|
Softgel capsule
|
Over-The-Counter (OTC)
|
Alu-PVC Blister Pack x 10's (Box of 30's and 100's)
|
-
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
05 February 2020
|
05 February 2025
|
View |
|
DRP-8695
|
Orlistat
|
Xiomic
|
120 mg
|
Capsule
|
Over-The-Counter (OTC)
|
Alu/PVC/PVDC Blister Pack x 21's (Box of 21's)
|
-
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
05 February 2020
|
05 February 2025
|
View |
|
DRP-8696
|
Pemetrexed (as disodium heptahydrate)
|
Pemestal-100
|
100 mg
|
Lyophilized Powder For Intravenous Injection
|
Prescription Drug (RX)
|
USP Type I clear moulded glass vial (Box of 1's)
|
-
|
Admac Lifesciences
|
India
|
|
Ambica International Crop.
|
Ambica International Crop.
|
-
|
05 February 2020
|
05 February 2025
|
View |
|
DRP-8696-01
|
Pemetrexed (as disodium heptahydrate)
|
Trexed
|
100 mg
|
Lyophilized Powder for Intravenous Infusion
|
Prescription Drug (Rx)
|
USP Type I clear moulded glass vial (Box of 1’s)
|
Antineoplastic (Folic Acid Analogue)
|
ADMAC Lifesciences
|
India
|
N/A
|
Ambica International Corporation
|
Unilab, Inc.
|
CLIDP Conversion
|
25 October 2023
|
05 February 2025
|
View |
|
DRP-8697
|
Pemetrexed (as disodium Hemipetahydrate)
|
Prixanep-100
|
100 mg
|
Lyophilized Powder For Intravenous Infusion
|
Prescription Drug (RX)
|
USP Type I Glass vial with grey bromo butyl stopper and an aluminum seal with grey cap (Box of 1's)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Crop.
|
Ambica International Crop.
|
-
|
05 February 2020
|
05 February 2025
|