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BRP-109_PI_01.pdf
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BRP-109
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Epoetin Alfa
|
Wepox 4000
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
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Prescription Drug (Rx)
|
Single dose. USP Type I Pre-filled Glass Syringe x 1 mL (Box of 1's)
|
-
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Wockhardt Ltd
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India
|
N/A
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Ambica International Corporation
|
Ambica International Corporation
|
-
|
24 June 2022
|
21 April 2025
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View |
BRP-109-01_PI_01.pdf
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BRP-109-01
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Epoetin Alfa
|
Epo-Ace
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
Single dose. USP Type I Pre-filled Glass Syringe x 1 mL (Box of 1's)
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Antianemic Preparations
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Wockhardt Ltd.
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India
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N/A
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Ambica International Corporation
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Genace Pharma Distributor
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Renewal
|
26 July 2024
|
21 April 2030
|
View |
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BRP-110
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Rituximab
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Rixathon
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500 mg/50 mL (10mg/mL)
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Concentrate For Solution For Infusion (IV)
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Prescription Drug (RX)
|
Type I colorless glass vial with chlorobutyl rubber stopper and aluminum seal with flip-off cap x 50mL (Box of 1's)
|
-
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Lek Pharmaceuticals D.D
|
Slovenia
|
N/A
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Sandoz Philippines Corporation
|
Sandoz Philippines Corporation
|
Initial
|
27 June 2022
|
27 June 2027
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View |
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BRP-111
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Rituximab
|
Rixathon
|
100 mg/10 mL (10mg/mL)
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Concentrate For Solution For Infusion (IV)
|
Prescription Drug (RX)
|
Type I colorless glass vial with chlorobutyl rubber stopper and aluminum seal with flip-off cap x 10mL (Box of 2's)
|
-
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Lek Pharmaceuticals D.D
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Slovenia
|
N/A
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Sandoz Philippines Corporation
|
Sandoz Philippines Corporation
|
Initial
|
27 June 2022
|
27 June 2027
|
View |
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BRP-112
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Trastuzumab
|
Ogivri
|
150 mg
|
Lyophilized Powder for Concentrate for Solution
for Infusion (IV)
|
Prescription Drug (RX)
|
Single dose. 15 mL Type I glass vial with grey chlorobutyl rubber stopper sealed with aluminum and lavender plastic flip-off cap (Box of 1's)
|
Monoclonal Antibodies (HER2 Inhibitors)
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Biocon Biologics India Limited
|
India
|
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Mylan Philippines, Inc.
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Mylan Philippines, Inc.
|
Initial (Re-application)
|
22 July 2022
|
22 July 2027
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View |
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BRP-113
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Trastuzumab
|
Ogivri
|
420 mg
|
Lyophilized Powder for Concentrate for Solution
for Infusion (IV)
|
Prescription Drug (RX)
|
Single dose. 50 mL Type I glass vial with grey chlorobutyl rubber stopper sealed with aluminum and lavender plastic flip-off cap (Box of l’s)
|
Monoclonal Antibodies (HER2 Inhibitors)
|
Biocon Biologics India Limited
|
India
|
|
Mylan Philippines, Inc.
|
Mylan Philippines, Inc.
|
Initial (Re-application)
|
22 July 2022
|
22 July 2027
|
View |
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BRP-114
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Lactobacillus gasseri + Lactobacillus rhamnosus
|
Ecovag
|
Hard Vaginal Capsule
|
|
Prescription Drug (Rx)
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Aluminum Tube with Polyethylene Desiccant Stopper x 10's (Box of 1's and 4's)
|
-
|
Deerland Probiotics & Enzymes A/S
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Denmark
|
N/A
|
Zeus Resources, Inc
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AJ Research & Pharma Inc.
|
PCPR Conversion
|
16 August 2022
|
20 September 2026
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View |
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BRP-115
|
Filgrastim
|
Topneuter
|
300mcg/mL
|
Solution for Injection (IV/SC)
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Prescription Drug (Rx)
|
1 mL in 2 mL Type I Borosilicate Glass Vial with Butyl Rubber Closure and Aluminum Seal (Box of 1's)
|
-
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Xiamen Amoytop Biotech Co., Ltd.
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China
|
N/A
|
Pharmakon Biotec Inc.
|
Pharmakon Biotec Inc.
|
-
|
01 September 2022
|
24 August 2026
|
View |
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BRP-115-01
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Filgrastim
|
Filgria
|
300 mcg/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
1 mL in 2 mL Type I Borosilicate Glass Vial with Butyl Rubber Closure and Aluminum Seal (Box of 1's)
|
Immunostimulant
|
Xiamen Amoytop Biotech Co., Ltd
|
China
|
N/A
|
Pharmakon Biotec Inc.
|
Teramedix Pharma Trading Inc
|
CLIDP Conversion
|
12 October 2022
|
24 August 2026
|
View |
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BRP-116
|
Filgrastim
|
Topneuter
|
150 mcg/mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
1 mL in 2 mL Type I Borosilicate Glass Vial with Butyl Rubber Closure and Aluminum Seal (Box of 1's)
|
-
|
Xiamen Amoytop Biotech Co., Ltd.
|
China
|
N/A
|
Pharmakon Biotec Inc.
|
Pharmakon Biotec Inc.
|
PCPR Conversion
|
03 October 2022
|
24 August 2026
|
View |
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BRP-117
|
Urofollitropin
|
Endogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
|
Prescription Drug (Rx)
|
2 mL USP Type I clear glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal (urofollitropin as drug product)+ 2 mL (Net content: 1 mL) USP Type I clear glass ampoule (0.9% sodium chloride as diluent) (Box of l's)
|
-
|
Sanzyme (P) Ltd.
|
India
|
N/A
|
MedEthix Inc.
|
MedEthix Inc.
|
PCPR Conversion
|
30 January 2023
|
11 April 2027
|
View |
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BRP-118
|
Menotrophin
|
Gynogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
|
Prescription Drug (Rx)
|
2 mL USP Type I clear glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal (menotrophin as drug product)+ 2 mL (Net cont ent: 1 mL) USP Type I clear glass ampoule (0. 9% sodium chloride as diluent) (Box of 1's)
|
-
|
Sanzyme (P) Ltd.
|
India
|
N/A
|
MedEthix Inc
|
MedEthix Inc
|
PCPR Conversion
|
30 December 2022
|
11 April 2027
|
View |
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BRP-119
|
Human Chorionic Gonadotrophin
|
Pubergen
|
5000 IU
|
Lyophilized Powder for Injection (IM)
|
Prescription Drug (Rx)
|
1 Lyophilized powder in a 2mL USP Type I clear glass vial + 1 mL Sodium Chloride solution in glass ampoule in a sealed clear plastic tray per box (Box of 1's)
|
-
|
Sanzyme (P) Ltd.
|
India
|
N/A
|
Medethix, Inc.
|
Medethix, Inc
|
PCPR Conversion
|
30 December 2022
|
11 April 2027
|
View |
|
BRP-120
|
Trastuzumab
|
Ogivri
|
420 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Prescription Drug (RX)
|
Packaging: Multidose. 50 mL Type I borosilicate glass vial with grey chlorobutyl rubber stopper sealed with lavender aluminum and propylene flip-off cap + 20 mL Type I borosilicate glass vial with grey chlorobutyl rubber stopper sealed with red aluminum and propylene flip-off cap [Bacteriostatic Water for Injection (BWFI) as diluent] (Box of l's).
|
-
|
Biocon Biologics India Limited
|
India
|
Mylan Pharmaceuticals Private Limited
|
Viatris Pharmaceuticals, Inc.
|
Viatris Pharmaceuticals, Inc.
|
Initial
|
24 January 2023
|
24 January 2028
|
View |
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BRP-122
|
Bevacizumab
|
Bonmab
|
100 mg/4 mL (25 mg/ mL)
|
Concentrate for Solution for
Infusion (IV)
|
Prescription Drug (RX)
|
4 mL in 6 mL EP Type I glass vial with bromobutyl rubber stopper and aluminum seal with plastic flip-off
er stopper cap (Box of 1's).
|
-
|
Joint Stock Company Biocad
|
Russia
|
N/A
|
Ambitech Biopharmaceuticals Inc.
|
Ambitech Biopharmaceuticals Inc.
|
Initial (Re-Application)
|
03 April 2023
|
03 April 2028
|
View |
|
BRP-123
|
Bevacizumab
|
Bonmab
|
400 mg/16 mL (25 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
Prescription Drug (RX)
|
16 mL in 20 mL EP Type I glass vial with bromobutyl rubber stopper and aluminum seal with plastic flip-off cap (Box of 1's).
|
-
|
Joint Stock Company Biocad
|
Russia
|
N/A
|
Ambitech Biopharmaceuticals Inc.
|
Ambitech Biopharmaceuticals Inc.
|
Initial (Re-Application)
|
03 April 2023
|
03 April 2028
|
View |
|
BRP-124
|
Insulin Human (rDNA)
|
Scilin M30
|
30% Soluble Insulin + 70% Isophane Insulin 100 IU/mL
|
Suspension for Injection (SC)
|
Prescription Drug (Rx)
|
Clear and colorless glass vial X 10 mL with combiseal / (Box of 1's)
|
Insulins and Analogues
|
Bioton S.A.
|
Poland
|
|
Metro Drug, Inc
|
Metro Drug, Inc
|
Renewal
|
07 April 2024
|
05 April 2029
|
View |
|
BRP-1263
|
Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B (rDNA) and Haemophilus influenzae type b conjugate vaccine
|
Eupenta
|
[see reverse]
|
Solution for IM Injection
|
Prescription Drug (Rx)
|
0.5 mL colorless glass vial, with grey rubber stopper and Aluminum flip-off cap seal
|
-
|
LG Chem Ltd.
|
Korea
|
|
Glovax Biotech Corp.
|
Glovax Biotech Corp.
|
Automatic Renewal
|
03 January 2023
|
13 March 2028
|
View |
|
BRP-1264
|
Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B (rDNA) and Haemophilus influenzae type b conjugate vaccine
|
Eupenta
|
0.5mL
|
Solution for IM Injection
|
Prescription Drug (Rx)
|
5.0 mL colorless glass vial, with grey rubber stopper and Aluminum flip-off cap seal
|
-
|
LG Chem Ltd.
|
Korea
|
|
Glovax Biotech Corp.
|
Glovax Biotech Corp.
|
Automatic Renewal
|
04 January 2023
|
13 March 2028
|
View |
|
BRP-130
|
Trastuzumab
|
Herticad
|
440 mg
|
Powder for Concentrate for Solution for Infusion.
|
Prescription Drug (RX)
|
Each box contains: Type I borosilicate glass vial with grey bromobutyl rubber stopper and aluminum seal with polypropylene flip-off cap (as Trastuzumab) + Type I borosilicate glass vial with grey bromobutyl rubber stopper and aluminum seal with polypropylene flip-off cap (as Bacteriostatic Water for Injection) x 20 mL.
|
Monoclonal Antibodies
|
Joint Stock Company Biocad
|
Russia
|
N/A
|
Ambitech Biopharmaceuticals Inc.
|
Ambitech Biopharmaceuticals Inc.
|
Initial (Reapplication)
|
09 November 2023
|
09 November 2028
|