| View |
|
DRP-9119
|
AZITHROMYCIN (as monohydrate)
|
Maxzith Iv
|
500mg
|
Lyophilized Power for Solution for Intravenous Infusion
|
Prescription Drug (RX)
|
10 mL capacity USP Type I clear glass vial stoppered
with bromobutyl rubber stopper and sealed with aluminium blue flip-off seal (Box of l's)
|
-
|
Gland Pharma Limited
|
India
|
|
Biocare Lifesciences, Inc.
|
Biocare Lifesciences, Inc.
|
-
|
20 October 2020
|
20 October 2025
|
| View |
|
DRP-9120
|
Calcium
|
Unbranded
|
500mg Elem. Calcium
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/PVDC/PVC Blister Pack x 10's (Box of 100's)
|
Mineral
|
Medicamen Biotech Ltd.
|
India
|
|
Uniqure Pharma Inc.
|
Uniqure Pharma Inc.
|
Renewal
|
21 March 2023
|
04 September 2028
|
| View |
|
DRP-9121
|
Zinc
|
Zincoral
|
50mg (Equivalent to 137.5mg Zinc Sulfate Monohydrate)
|
Tablet
|
Over-The-Counter (OTC)
|
Alu-PVC/PVDC Blister x 10's (Box of 30's and 100's)
|
-
|
Kanion Pharmaceutical Co., Ltd
|
China
|
|
AMB HK Enterprises Inc.
|
|
-
|
04 September 2020
|
04 September 2025
|
| View |
|
DRP-9122
|
Omeprazole (As Sodium)
|
Oprex
|
40 mg
|
Lyophilized Powder For Injection (IV)
|
Prescription Drug (RX)
|
USP Type 1 tubular glass vial with rubber stopper and flip-off cap (Box of 10's)
|
-
|
reyoung Pharmaceuticals Co., Ltd
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
04 September 2020
|
04 September 2025
|
| View |
|
DRP-9122-01
|
Omeprazole (as sodium)
|
Omeden
|
40 mg Lyophilized
|
Powder for Injection (I.V.)
|
Prescription Drug (Rx)
|
USP Type 1 tubular glass vial with rubber stopper and flipoff cap (Box of 10's)
|
Proton Pump Inihibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
Cyden Medicale Trading Inc.
|
CLIDP Conversion
|
23 July 2022
|
04 September 2025
|
| View |
|
DRP-9123
|
Pyrazinamide
|
None
|
250 mg/5 mL
|
Oral Suspension
|
Prescription Drug (RX)
|
Amber boston round bottle x 60 mL
|
-
|
Lloyd Laboratories Inc.
|
Philippines
|
|
|
|
Initial
|
04 September 2020
|
04 September 2025
|
| View |
|
DRP-9124
|
Lactulose
|
Easelac
|
3.33g/5mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET Bottle x 120 mL with 10mL Plastic measuring cap
(Box of x 1's)
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
|
Pharmkon Biotec Inc.
|
|
-
|
04 September 2020
|
04 September 2025
|
| View |
|
DRP-9124-01
|
Lactulose
|
Luzlax
|
3.33g/5mL Oral Solution
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET bottle x 120mL
with 10 mL plastic measuring cap
(Box of 1's)
|
-
|
MAGBRO HEALTHCARE PVT.LTD.
|
India
|
|
PHARMAKON BIOTEC INC.
|
TERAMEDIX PHARMA TRADING INC.
|
-
|
31 August 2021
|
04 September 2025
|
| View |
|
DRP-9124-02
|
Lactulose
|
Zulose
|
3.33g/5mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET bottle x 120mL
with 10 mL plastic measuring cap
(Box of 1's)
|
-
|
MAGBRO HEALTHCARE PVT.LTD.
|
India
|
|
PHARMAKON BIOTEC INC.
|
TERAMEDIX PHARMA TRADING INC.
|
-
|
03 September 2021
|
04 September 2025
|
| View |
|
DRP-9124-03
|
Lactulose
|
Laxseri
|
3.33g/5mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET Bottle x 120 mL with 10 mL Plastic
Measuring Cup(Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Pharmakon Biotec Inc.
|
PHARMAKON BIOTEC INC.
|
TERAMEDIX PHARMA TRADING INC.
|
Initial [CLIDP]
|
22 October 2021
|
04 September 2025
|
| View |
|
DRP-9124-04
|
Lactulose
|
Laxac
|
3.33 g/5 mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET bottle x 120 mL with 10 mL Plastic
Measuring Cap (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd
|
India
|
|
Pharmakon Biotec Inc.
|
Alkem Laboratories Corporation
|
Initial
|
24 December 2021
|
04 September 2025
|
| View |
|
DRP-9124-05
|
Lactulose
|
Wizlax
|
3.33g/5mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET bottle x 120mL with 10mL plastic measuring cap (Box of l’s)
|
Laxative
|
Magbro Healthcare Pvt. Ltd.
|
India
|
N/A
|
Pharmakon Biotec Inc.
|
Teramedix Pharma Trading Inc.
|
CLIDP
|
21 January 2022
|
04 September 2025
|
| View |
|
DRP-9124-06
|
Lactulose
|
Dixilose
|
3.33g/5 mL
|
Oral Solution
|
Prescription Drug (RX)
|
Amber PET bottle x 120 mL with 10 mL plastic
measuring cap (Box of 1's)
|
Laxative
|
Magbro Healtcare Pvt. Ltd.
|
India
|
N/A
|
Pharmakon Biotec Inc.
|
Teramedix Pharma Trading Inc.
|
CLIDP
|
24 February 2022
|
04 September 2025
|
| View |
|
DRP-9124-07
|
Lactulose
|
Cleargut
|
3.33g / 5 mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Amber PET bottle x 120 mL with 10 mL plastic measuring cap (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd.
|
India
|
N/A
|
Pharmakon Biotec Inc.
|
Alkem Laboratories Corporation
|
CLIDP Conversion
|
11 September 2023
|
04 September 2025
|
| View |
|
DRP-9124-08
|
Lactulose
|
Consilose
|
3 .33g / 5 mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Amber PET bottle x 120 mL with 10 mL plastic measuring cap (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd
|
India
|
N/A
|
Pharmakon Biotec Inc
|
Teramedix Pharma Trading Inc
|
CLIDP Conversion
|
16 November 2023
|
04 September 2025
|
| View |
|
DRP-9124-09
|
Lactulose
|
Lactera
|
3.33g / 5 mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Amber PET bottle x 120 mL with 10 mL plastic measuring cap (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd
|
India
|
N/A
|
Pharmakon Biotec Inc.
|
Teramedix Pharma Trading Inc
|
CLIDP Conversion
|
15 November 2023
|
04 September 2025
|
| View |
|
DRP-9124-10
|
Lactulose
|
Lactuden
|
3.33g / 5 mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Amber PET bottle x 120 mL with 10 mL plastic measuring cap / (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd.
|
India
|
|
Pharmakon Biotec Inc.
|
Cyden Medicale Trading Inc.
|
CLIDP Conversion
|
10 March 2024
|
04 September 2025
|
| View |
|
DRP-9124-11
|
Lactulose
|
Dylac
|
3.33g / 5mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Amber PET bottle x 120 mL with 10 mL plastic measuring cap / (Box of 1's)
|
Laxative
|
Magbro Healthcare Pvt. Ltd
|
India
|
|
Pharmakon Biotec Inc.
|
Dynasty Pharmaceuticals
|
CLIDP Conversion
|
10 June 2024
|
04 September 2025
|
| View |
|
DRP-9125
|
Fluphenazine Decanoate
|
Sydepres
|
25mg/mL
|
Solution for Injection (IM/SC)
|
Prescription Drug (RX)
|
USP Type I amber-colored glass ampoule with red band x 1mL in PVC tray (Box of 5's)
|
-
|
SM Pharmaceutical (M) Sdn. Bhd.
|
Malaysia
|
|
Duopharma Trade Phils. Inc.
|
Rotex Pharma Phils., Inc.
|
-
|
01 December 2021
|
18 September 2025
|
| View |
|
DRP-9125-01
|
Fluphenazine decanoate
|
Fludozine
|
25 mg/mL
|
Solution for Injection (I.M/S.C)
|
Prescription Drug (Rx)
|
USP Type I Amber-Colored Glass Ampoule with Red Band x 1 mL in PVC Tray (Box of 5's)
|
Antipsychotic (Phenothiazine with Piperazine Structure)
|
SM Pharmaceutical (M) Sdn. Bhd.
|
Malaysia
|
N/A
|
Duopharma Trade Phils., Inc
|
PNF Pharmaceutical, Inc
|
CLIDP Conversion
|
25 October 2022
|
18 September 2025
|