| View |
|
BRP-036-01
|
Isophane Insulin Human (Rdna Origin)
|
Glysolin N
|
100 I.U./ mL
|
Suspension For Injection (S.C.)
|
Prescription Drug (RX)
|
10 mL glass vial with rubber stopper and green flip-off seal
|
Intermediate acting insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corporation
|
The Cathay Drug Co., Inc.
|
Automatic Renewal
|
18 July 2022
|
06 September 2027
|
| View |
|
BRP-036-02
|
Isophane Insulin Human (Rdna Origin)
|
Excel-Insu N
|
100 IU/mL
|
Suspension For Injection (Sc)
|
Prescription Drug (RX)
|
10mL glass vial with rubber stopper and green flip-off seal (Box of 1's)
|
Intermediate acting insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corporation
|
Team Excel Distibution Inc.
|
Automatic Renewal
|
18 July 2022
|
06 September 2027
|
| View |
|
BRP-036-03
|
Isophane Insulin Human (rDNA Origin)
|
Lupinsulin-N
|
100 IU/mL
|
Suspension For Injection (SC)
|
Prescription Drug (RX)
|
10 mL Glass Vial with Rubber stopper and Green Flip
off Seal (Box of 1’s)
|
Intermediate acting insulin
|
Wockhardt Limited
|
India
|
N/A
|
Ambica International Corporation
|
Multicare Pharmaceuticals Phils. Inc.
|
Automatic Renewal
|
08 July 2022
|
06 September 2027
|
| View |
|
BRP-036-04
|
Isophane Insulin Human (rDNA Origin)
|
None
|
100 IU/mL
|
Suspension for Injection (SC)
|
Prescription Drug (RX)
|
10 mL glass vial with rubber stopper and green flip
off seal (Box of 1's)
|
Intermediate acting insulin
|
Wockhardt Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
Automatic Renewal
|
13 July 2022
|
06 September 2027
|
| View |
|
BRP-037
|
Insulin Glargine
|
Glaritus
|
100IU/mL
|
Solution for Injection (SC)
|
Prescription Drug (RX)
|
3mL USP Type I Clear glass catridge with pen delivery device (Box of 1's)
|
Long-acting Insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corp.
|
Ambica International Corp.
|
Renewal
|
28 January 2019
|
03 March 2029
|
| View |
|
BRP-037-01
|
Insulin Glargine
|
Glysolin G
|
100 IU/mL
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
3mL USP Type I Clear glass catridge with pen delivery device (Box of 1's)
|
Long-acting Insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corporation
|
THE CATHAY YSS DISTRIBUTORS CO., INC
|
Renewal
|
16 November 2023
|
03 March 2029
|
| View |
|
BRP-037-03
|
Insulin Glargine
|
Glarsulin
|
100 IU/mL
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
3mL USP Type I Clear glass catridge with pen delivery device (Box of 1's)
|
Long-acting Insulin
|
Wockhardt Ltd.
|
India
|
|
Ambica International Corporation
|
Detoxicare Philippines, Inc.
|
Renewal
|
22 November 2023
|
03 March 2029
|
| View |
|
BRP-037-04
|
Insulin Glargine
|
Ylateq
|
100 IU/mL
|
Solution for Injection (SC)
|
Prescription Drug (Rx)
|
3 mL USP Type I Clear Glass Cartridge with Pen Delivery Device Box of 1's
|
Long-acting Insulin
|
Wockhardt Limited
|
India
|
N/A
|
Ambica International Corporation
|
Unilab, Inc
|
Renewal
|
16 November 2023
|
03 March 2029
|
| 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-038-02
|
Isophane Insulin Human, Recombinant DNA
|
Unbranded
|
100 IU/mL
|
Suspension for Injection (SC)
|
Prescription Drug (RX)
|
USP Type I clear and colourless glass cartridge x 3 mL (Box of 1's)
|
Intermediate-acting Insulin
|
Wockhardt Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
Renewal
|
23 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-039-01
|
Heparin Sodium
|
Hemolate
|
5000 IU/ mL (25000 IU/mL)
|
Solution for Injection (IV/SC)
|
Prescription Drug (Rx)
|
5 mL USP Type I amber glass vial / (Box of 10's)
|
Anticoagulant
|
Troikaa Pharmaceuticals Limited
|
India
|
|
Troikaa Pharmaceuticals Philippines Inc.
|
Ellebasy Medicale Group Inc
|
CLIDP Conversion
|
10 March 2024
|
02 January 2027
|
| View |
|
BRP-040
|
Enoxaparin Sodium
|
Noxadium 6000
|
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
|
Central West Medicale Inc.
|
Renewal (Reconstruction)
|
06 August 2024
|
30 January 2028
|
| 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-040-02
|
Enoxaparin Sodium
|
Vintrenox
|
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
|
Vintel Med Enterprises
|
Initial (Reconstruction)
|
06 August 2024
|
09 December 2025
|
| View |
|
BRP-040-03
|
Enoxaparin Sodium
|
Enoxbicare-60
|
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
|
Ambicare Pharmaceuticals Inc.
|
Initial (Reconstruction)
|
06 August 2024
|
09 December 2025
|
| View |
|
BRP-040-04
|
Enoxaparin sodium
|
Noxprivex
|
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
|
Sonchel Pharma Distributors
|
Initial (Reconstruction)
|
06 August 2024
|
09 December 2025
|
| View |
|
BRP-040-05
|
Enoxaparin Sodium
|
Enoxbasy 60
|
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 blister pack)
|
-
|
Brawn Laboratories Ltd.
|
India
|
|
Ambica International Corporation
|
Diafarm Inc.
|
Initial (CLIDP)
|
12 August 2021
|
09 December 2025
|
| View |
|
BRP-040-06
|
Enoxaparin Sodium
|
Goxaparin
|
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
|
-
|
Brawn Laboratories Ltd
|
India
|
|
Ambica International Corporation
|
Applied Pharmaceutical Distribution Inc.
|
-
|
13 September 2021
|
09 December 2025
|