| View |
|
BRP-086
|
Human Normal Immunoglobulin
|
Bioven Mono
|
50mg/Ml (5% w/v)
|
Solution For Injection (I.V.)
|
Prescription Drug (RX)
|
Type I glass vial with bromobutyl rubber stopper sealed with aluminum cap x 50ml and 100mL (Box of 1's)
|
Immunoglobulin
|
Biofarma Plasma Limited Liability Company
|
Ukraine
|
|
Ambicare Pharmaceuticals, Inc.
|
|
Renewal
|
05 December 2023
|
29 May 2029
|
| View |
|
BRP-087
|
Epoietin Alfa
|
Gepotin
|
4,000IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
1 mL prefilled syringe with needle in sealed plastic tray (Box of 5's)
|
Other Antianemic Preparations
|
NCPC Genetech Biotechnology Co., Ltd.
|
China
|
|
CDM Marketing Center
|
CDM Marketing Center
|
Renewal
|
19 March 2024
|
05 May 2029
|
| View |
|
BRP-089
|
Enoxaparin Sodium
|
Hepaclex
|
40 mg/0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL USP Type I pre-filled glass syringe with 27G x 1⁄2 inch needle, packed in PVC/paper blister (Box of 6 pre- filled syringe in individual cartons)
|
Antithrombotic Agents
|
Gland Pharma Limited
|
India
|
|
Endure Medical, Inc.
|
|
Renewal
|
07 March 2024
|
04 June 2028
|
| View |
|
BRP-090
|
Equine Anti-Rabies Immunoglobulin
|
Vinrab
|
200 IU/mL (1000 IU/5mL)
|
Solution For Injection I.M
|
Prescription Drug (RX)
|
5mL Glass vial in a Box (Box of 10's)
|
Immunoglobulins
|
Vins Bioproducts, Ltd.
|
India
|
|
IP Biotech Inc.
|
Ambica International Corporation
|
Renewal
|
21 March 2024
|
16 March 2029
|
| View |
|
BRP-090-01
|
Equine Anti-rabies Immunoglobulin
|
Zenuine
|
200 IU/mL (1,000 IU/5 mL)
|
Solution for Injection (IM)
|
Prescription Drug (Rx)
|
Glass Vial x 5 mL in a Box / (Box of 10's)
|
Immunoglobulins
|
Vins Bioproducts, Ltd.
|
India
|
|
IP Biotech, Inc
|
Ambicare Pharmaceuticals Inc
|
Renewal
|
05 April 2024
|
16 March 2029
|
| View |
|
BRP-091
|
Epoetin Alfa
|
Binocrit
|
40,000 IU/ mL
|
Solution For Injection (IV/SC)
|
Prescription Drug (Rx)
|
1 Box Hold 1 blister containing type I Clear Pre-filled syringe x 1mL with 27 G 1/2 needle and needle Safety guard, with bromobutyl rubber plunger stopper
|
-
|
IDT Biologika GmbH
|
Germany
|
|
Sandoz Philippines Corporation
|
|
-
|
02 April 2020
|
02 April 2025
|
| View |
|
BRP-092
|
Epoetin Alfa
|
Binocrit
|
4,000 IU/ 0.4 Ml
|
Solution For Injection (IV/SC)
|
Prescription Drug (Rx)
|
1 Box Hold 6 blister containing type I Clear Pre-filled syringe x 0.4mL with 27 G 1/2 needle and needle Safety guard, with bromobutyl rubber plunger stopper
|
-
|
IDT Biologika GmbH
|
Germany
|
|
Sandoz Philippines Corporation
|
|
-
|
02 April 2020
|
02 April 2025
|
| View |
|
BRP-093
|
Heparin sodium
|
Bruhep 25000
|
5000 IU/mL
|
Solution For Injection (Iv/Sc)
|
Prescription Drug (RX)
|
5 mL USP Type I Clear Glass Vial (Box of l's)
|
Anticoagulants
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
01 February 2024
|
30 April 2029
|
| View |
|
BRP-093-01
|
Heparin sodium
|
Hepravasc-5000
|
5000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
USP Type I Clear Glass Vial X 5 mL / (Box of 1's)
|
AntithromAgentsbotic
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Ambitech Biopharmaceuticals Inc.
|
Automatic Renewal
|
01 March 2024
|
30 April 2029
|
| View |
|
BRP-093-02
|
Heparin sodium
|
Heprabica-5000
|
5,000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
5 mL USP Type I Clear Glass Vial (Box of 1’s)
|
Anticoagulants
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
Renewal
|
12 March 2024
|
30 April 2029
|
| View |
|
BRP-093-03
|
Heparin sodium
|
Hepamedica
|
5000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
USP Type I Clear Glass Vial X 5 mL / (Box of 1's)
|
Antithrombotic Agents
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Rifemedica Corporation
|
CLIDP Conversion
|
06 March 2024
|
30 April 2029
|
| View |
|
BRP-093-04
|
Heparin sodium
|
Unbranded
|
5,000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
5 mL USP Type I Clear Glass Vial (Box of 1's)
|
Anticoagulants
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Ritemed Phils., Inc
|
Renewal
|
10 March 2024
|
30 April 2029
|
| View |
|
BRP-094
|
HEPARIN SODIUM
|
SAKARIN 25000
|
5000 IU/mL
|
Solultion For Injection (IV/SC)
|
Prescription Drug (RX)
|
USP Type I Amber Glass Vial x 5 mL (Box of 1's)
|
ANTITHROMBOTIC AGENT
|
Sakar Healthcare Pvt. Ltd.
|
India
|
|
Macropharma Corporation
|
Macropharma Corporation
|
Renewal
|
08 March 2021
|
28 November 2028
|
| View |
|
BRP-095
|
HEPARIN SODIUM
|
SAKARIN 5000
|
1000 IU/mL
|
Solution For Injection (IV/SC)
|
Prescription Drug (RX)
|
5 mL USP Type I Amber Glass Vial (Box of 1's)
|
ANTICOAGULANT
|
Sakar Healthcare Pvt. Ltd.
|
India
|
N/A
|
Macropharma Corporation
|
Macropharma Corporation
|
Renewal
|
29 March 2024
|
20 May 2029
|
| View |
|
BRP-096
|
Enoxaparin Sodium
|
Olxarin
|
8,000 IU/0.8mL (80mg/0.8mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
0.8 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
BRP-097
|
Enoxaparin Sodium
|
Olxarin
|
6,000 IU/0.6mL (60 mg/0.6mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
0.6 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
BRP-097-01
|
Enoxaparin sodium
|
Emoxin
|
6,000 IU/0.6 mL (60 mg/0.6 mL)
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.6 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
Anticoangulant
|
Hangzhou Jiuyuan Gene Engineering Co. Ltd
|
China
|
N/A
|
Sahar International Trading Inc
|
Amson Pharmaceuticals
|
-
|
20 January 2022
|
04 April 2025
|
| View |
|
BRP-098
|
Enoxaparin Sodium
|
Olxarin
|
4,000 IU/0.4mL (40 mg/0.4 mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL Pre-filled glass syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
24 September 2021
|
17 April 2025
|
| View |
|
BRP-099
|
Enoxaparin Sodium
|
Olxarin
|
2,000 IU/0.2 mL (20mg/0.2 mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
0.2 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
BRP-100
|
Epoetin Alfa
|
Epiao
|
4000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
1 ml Type I pre-filled glass syringe with chlorobutyl
plunger stopper and stainless-steel needle with a polyisoprene needle shield and sealed in blister (Box of los)
|
Antianemic Preparations
|
Shenyang Sunshine Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial
|
14 December 2021
|
14 December 2026
|