| View |
|
BRP-041-10
|
Enoxaparin Sodium
|
Sanovince
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Sanoviz Pharmaceutical Products Trading
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-11
|
Enoxaparin sodium
|
Noxhart 4000
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Belasram Farma Trading
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-12
|
Enoxaparin Sodium
|
Senorin
|
4000 IU anti-Factor Xa (equivalent to 40 mg/0.4 mL
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
Antithrombotic agents
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Starpharm, Inc.
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-13
|
Enoxaparin Sodium
|
Coranox
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Enoxaparin Sodium
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
Antithrombotic Agents
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Macropharma Corporation
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-14
|
Enoxaparin Sodium
|
Dynaxaparin
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
Antithrombotic agents
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Dynasty Pharmaceuticals
|
Initial (Revalidation) (Reconstruction).
|
31 July 2024
|
09 December 2025
|
| View |
|
BRP-041-15
|
Enoxaparin Sodium
|
Tamparin
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-16
|
Enoxaparin Sodium
|
Noxaclane
|
4000 IU anti-Factor Xa (equivalent to 40 mg)/0.4 mL
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.4 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Decano Drug Distribution Services
|
-
|
18 April 2022
|
09 December 2025
|
| View |
|
BRP-041-17
|
Enoxaparin sodium
|
Enoxfadz 4000
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister
Pack)
|
Anticoagulant
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
FADZ Pharma Inc.
|
Initial (Revalidation)
|
27 April 2022
|
09 December 2025
|
| View |
|
BRP-041-18
|
Enoxaparin sodium
|
Neoxaparin
|
4000 IU Anti-Factor Xa (Equivalent to 40mg) / 0.4mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4mL in 1 mL Pre-filled Syringe (Box of 1 Blister
Pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Neo-Care Philippines
|
-
|
21 April 2022
|
09 December 2025
|
| View |
|
BRP-041-19
|
Enoxaparin sodium
|
Carcenoxar
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister Pack)
|
-
|
Brawn Laboratories Ltd
|
India
|
N/A
|
Ambica International Corporation
|
Ambitech Biopharmaceuticals Inc.
|
CLIDP Conversion
|
20 January 2023
|
09 December 2025
|
| View |
|
BRP-041-20
|
Enoxaparin sodium
|
Enoxar
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister Pack)
|
Anticoagulant
|
Brawn Laboratories Limited
|
India
|
|
Ambica International Corporation
|
Uni-Pharma Phils., Inc
|
CLIDP Conversion
|
08 July 2023
|
09 December 2025
|
| View |
|
BRP-041-21
|
Enoxaparin sodium
|
Bicanoxen 40
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister Pack)
|
Anticoagulant
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Altomed Pharmaceuticals, Inc
|
CLIDP Conversion
|
15 August 2023
|
09 December 2025
|
| View |
|
BRP-041-22
|
Enoxaparin sodium
|
None
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister Pack)
|
Antithrombotic agents
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Ritemed Phils., Inc
|
CLIDP Conversion
|
12 November 2023
|
09 December 2025
|
| View |
|
BRP-041-23
|
Enoxaparin sodium
|
Noxever
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.4 mL in 1 mL Pre-filled Syringe (Box of 1 Blister Pack)
|
Antithrombotic agents
|
Brawn Laboratories Ltd
|
India
|
|
Ambica International Corporation
|
Pharma King Distributor
|
CLIDP Conversion
|
13 December 2023
|
09 December 2025
|
| View |
|
BRP-043
|
Streptokinase
|
St-Pase
|
1,500,000 IU/ vial
|
Powder For Injection (I.V.)
|
Prescription Drug (RX)
|
USP Type I Flint Glass Vial (Box of 1's)
|
Thrombolytic
|
Cadila Pharmaceuticals Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
13 June 2024
|
09 April 2030
|
| View |
|
BRP-043-01
|
Streptokinase
|
Corbistrep
|
1,500,000 IU/ vial
|
Powder For Injection (IV)
|
Prescription Drug (RX)
|
USP Type I Flint Glass Vial (Box of 1's)
|
Thrombolytic
|
Cadila Pharmaceuticals Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
Renewal
|
23 June 2024
|
09 April 2030
|
| View |
|
BRP-044
|
Human Albumin
|
Seroalbumin
|
200 g/L (20% w/v)
|
Solution for IV Infusion
|
Prescription Drug (RX)
|
50 mL and 100 mL USP Type I Glass Vial with Bromobutyl Rubber Stopper and Flip-off Aluminum Seal (Box of 1's)
|
-
|
Virchow Biotech Pvt. Ltd.
|
India
|
GSK Lifesciences Pvt. Ltd.
|
I.E. Medica Inc.
|
I.E. Medica Inc.
|
-
|
21 April 2021
|
09 February 2026
|
| View |
|
BRP-044-01
|
Human Albumin
|
Humin
|
200 g/L (20% w/v)
|
Solution for IV Infusion
|
Prescription Drug (Rx)
|
50 mL USP Type I Glass Vial with Bromobutyl Rubber Stopper and Flip-off Aluminum Seal (Box of 1's)
|
Plasma Fraction for Specific Use
|
Virchow Biotech Pvt. Ltd.
|
India
|
N/A
|
I.E. Medica Inc
|
JMN Brothers Pharma Limited, Inc.
|
CLIDP Conversion
|
19 October 2023
|
09 February 2026
|
| View |
|
BRP-048
|
Human Albumin
|
Alburel
|
20% w/v (200 mg/mL)
|
Solution for Infusion (I.V.)
|
Prescription Drug (RX)
|
50 mL and 100 mL Type I Clear and Colorless Glass
Vial with Light Brown-Colored Flip-off Cap (Box of 1's)
|
Plasma Fraction for Specific Use
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
28 June 2024
|
05 April 2030
|
| View |
|
BRP-049
|
Filgrastim
|
Religrast
|
300 mcg/0.5 mL
|
Solution for Injection (IV/SC)
|
Prescription Drug (RX)
|
0.5 mL Pre-Filled Type I Glass Syringe with Needle in a Box (Single-dose)
|
Colony Stimulating Factors
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
23 May 2022
|
28 September 2027
|