| View |
|
BRP-038
|
Isophane Insulin Human, Recombinant DNA
|
Wosulin-N
|
100 I.U./mL
|
Suspension For Injection (Sc)
|
Prescription Drug (RX)
|
USP Type I Clear and Colorless Glass Cartridge x 3 mL
|
Intermediate-acting Insulin
|
Wockhardt Limited
|
India
|
|
Ambica International Corporation
|
GX International, Inc.
|
Renewal
|
10 January 2019
|
29 March 2029
|
| View |
|
BRP-038-01
|
Isophane Insulin Human, Recombinant DNA
|
Glysolin N
|
100IU/Ml
|
Suspension for Injection (SC)
|
Prescription Drug (RX)
|
USP Type I clear and colourless glass catridge x 3mL (Box of 1's)
|
Intermediate-acting Insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corp.
|
The Cathay YSS Distributors Co., Ltd.
|
Renewal
|
14 November 2023
|
29 March 2029
|
| View |
|
BRP-039
|
Heparin Sodium
|
Nuparin
|
5000 IU/mL
|
Solution For Injection
|
Prescription Drug (RX)
|
5ML USP TYPE I AMBER VIAL
|
Anticoagulant
|
Troikaa Pharmaceuticals Limited
|
India
|
|
Troikaa Pharmaceuticals Philippines, Inc.
|
Troikaa Pharmaceuticals Philippines, Inc.
|
Renewal
|
25 January 2022
|
02 January 2027
|
| View |
|
BRP-040-01
|
Enoxaparin Sodium
|
Rifoxane
|
6000 IU Anti-Factor Xa (equivalent to 60 mg)/0.6 mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
0.6 mL in 1 mL pre-filled syringe (Box of 1 blister pack)
|
Antithrombotic Agents
|
Brawn Laboratories Ltd.
|
India
|
N/A
|
Ambica International Corporation.
|
Rifemedica Corporation
|
Renewal (Reconstruction)
|
06 August 2024
|
09 December 2025
|
| View |
|
BRP-041-01
|
Enoxaparin Sodium
|
Noxadium 4000
|
4000 IU Anti-Factor Xa (equivalent to 40mg)/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
|
Central West Medicale Inc.
|
-
|
13 April 2022
|
09 December 2025
|
| View |
|
BRP-041-02
|
Enoxaparin Sodium
|
Rifoxane
|
4000 IU Anti-Factor Xa (equivalent to 40mg)/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
|
Rifemedica Corporation
|
-
|
13 April 2022
|
09 December 2025
|
| 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-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
|
| View |
|
BRP-049-01
|
Filgrastim
|
Grastigen
|
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. (Plant II)
|
India
|
|
Ambica International Corp.
|
Genace Pharma Distributor
|
Automatic Renewal
|
08 July 2022
|
28 September 2027
|
| View |
|
BRP-049-02
|
Filgrastim
|
Timgrastix
|
300mcg/0.5mL
|
Solution For Injection (Iv/Sc)
|
Prescription Drug (RX)
|
0.5 mLpre-filled Type I glass syringe with needle a box (Single-dose)
|
Hematopoietic Growth Factor
|
Reliance Life Scienve Pvt. Ltd. (Pant II)
|
India
|
|
Ambica International Corporation
|
D&G Pharma
|
Automatic Renewal
|
08 July 2022
|
28 September 2027
|
| View |
|
BRP-050
|
Recombinant Alfa-2B
|
Reliferon
|
3 million IU/0.5 mL
|
Solution For Injection (Im/Sc)
|
Prescription Drug (RX)
|
Type I Glass Vial x 0.5mL (Box of 1's). Single dose
|
Antineoplastic and Immunomodulating Agents (Interferons)
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Automatic Renewal
|
12 September 2022
|
21 November 2028
|
| View |
|
BRP-052
|
Human Normal Immunoglobulin
|
Immunorel
|
5% (50 mg/mL)
|
Solution for Infusion IV
|
Prescription Drug (RX)
|
Glass Vial x 10 mL, 20 mL, 50 mL, 100 mL, and 200 mL (Box of 1's)
|
Immunoglobulin
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Corp.
|
Ambica International Corp.
|
Renewal
|
24 May 2019
|
07 March 2029
|
| View |
|
BRP-052-01
|
Human Normal Immunoglobulin
|
Proivig
|
5% (50 mg/mL)
|
Solution for Infusion IV
|
Prescription Drug (RX)
|
Glass Vial x 50mL and 100mL (Box of 1's)
|
Immunoglobulins
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Corp.
|
Ambicare Pharmaceuticals, Inc.
|
Renewal
|
22 November 2023
|
07 March 2029
|
| View |
|
BRP-052-02
|
Human Normal Immunoglobulin
|
Immubulin
|
5% (50 mg/mL)
|
Solution for Infusion (IV)
|
Prescription Drug (RX)
|
Glass Vial x 50mL and 100mL (Box of 1's)
|
Immunoglobulins
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambica International Trading Corp.
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
Renewal
|
23 November 2023
|
07 March 2029
|
| View |
|
BRP-052-03
|
Human Normal Immunoglobulin
|
Normglubin
|
5% (50 mg/mL)
|
Solution For Iv Infusion
|
Prescription Drug (RX)
|
Glass vial x 50 mL and 100 mL (Box of 1's)
|
Immunoglobulins
|
Reliance Life Scienve Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
Renewal
|
23 November 2023
|
07 March 2029
|
| View |
|
BRP-052-04
|
Human Normal Immunoglobulin
|
Gamma-I.V.
|
5% (50mg/mL)
|
Solution For Infusion (I.V.)
|
Prescription Drug (RX)
|
Glass Vial x 50mL and 100mL (Box of 1's)
|
Immunoglobulins
|
Reliance Life Science Pvt. Ltd.
|
India
|
|
|
BSV Bioscience Phils. Inc.
|
Renewal
|
19 November 2023
|
07 March 2029
|
| View |
|
BRP-054
|
Biphasic Isophane Insulin Human (Recombinant DNA Origin)
|
Wosulin-30/70
|
100IU/mL
|
Suspension for Injection (SC)
(30% Regular Insulin Human/70% Isophane Insulin Human)
|
Prescription Drug (RX)
|
USP Type I clear and Colourless glass cartridge x 3mL (Box of 1's)
|
Intermediate-acting Insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corp.
|
GX Laboratories, Inc.
|
Renewal
|
28 January 2019
|
10 February 2029
|
| View |
|
BRP-055
|
Insulin Glargine
|
Toujeo
|
300 Units (equivalent to 10.91 mg)/mL
|
Powder For Oral Suspension Solution for
Injection (SC)
|
Prescription Drug (RX)
|
Type I colorless glass cartridge with bromobutyl rubber
plunger stopper and aluminum flanged cap with punch laminated sealing disk assembled in a pre-filled pen x 1.5 mL (Box of l's, 3's and 5's) (as commercial and physician's sample]
|
Antidiabetics
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
Sanofi-Aventis Philippines, Inc.
|
|
Initial (from Monitored Release)
|
27 June 2022
|
23 June 2026
|
| View |
|
BRP-056
|
Insulin Glargine
|
Lantus XR
|
300 Units (equivalent to 10.91 mg)/mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
Type I colorless glass cartridge with bromobutyl rubber plunger stopper and aluminum flanged cap with punch laminated sealing disk assembled in a pre-filled pen x 1.5 mL (Box of 1's, 3's and 5's).
|
Insulins and Analogues
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
Sanofi-Aventis Philippines, Inc.
|
Sanofi-Aventis Philippines, Inc.
|
Initial Variation]
|
19 April 2024
|
19 April 2029
|
| View |
|
BRP-057
|
Human Albumin
|
Humal
|
20% (0.2 g/mL)
|
Solution For Intravenous Infusion
|
Prescription Drug (RX)
|
50mL clear, colorless Type I glass vial
|
Plasma Fraction for Specific Use
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
|
Ambicare Pharmaceuticals, Inc.
|
Ambicare Pharmaceuticals, Inc.
|
Renewal
|
08 December 2023
|
09 May 2029
|