| View |
|
DRP-8873-02
|
Paracetamol
|
SONGESIC IV
|
10mg/mL (1g/100mL)
|
Solution for I.V. Infusion
|
Prescription Drug (Rx)
|
USP Type I clear, colorless glass bottle x 100 mL (Box of 1's)
|
Analgesic /Antipyretic
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
N/A
|
Asianmeds,Inc.
|
Sonchel Pharma Distributors
|
-
|
06 May 2022
|
21 May 2025
|
| View |
|
DRP-8874
|
Dutasteride
|
Prostmax
|
500mcg
|
Capsule
|
Prescription Drug (RX)
|
Alu-PVC/PE/PVDC Blister pack x 10's (box of 100's)
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
|
Triple Tact Import & Export Corp.,
|
Triple Tact Import & Export Corp.,
|
-
|
22 May 2020
|
22 May 2025
|
| View |
|
DRP-8874-01
|
Dutasteride
|
Prostezine
|
500 mcg
|
Capsule
|
Prescription Drug (RX)
|
Alu/PVC/PE/{VDC blister pack x 10's (Box of 100's)
|
5-Alpha-Reductase Inhibitor
|
Titan Laboratories Pvt. Ltd.
|
India
|
|
Triple Tact Import & Export Corp.
|
Greencore Pharma Inc.
|
Initial (CLIDP)
|
31 May 2021
|
22 May 2025
|
| View |
|
DRP-8875
|
Paracetamol
|
Sangesic
|
120mg/5mL
|
Syrup (Strawberry Flavor)
|
Over-the-Counter (OTC)
|
Boston Round Glass Amber Bottle x 60mL and 120mL (Box of 1's)
|
-
|
San Marino Laboratories Corp.
|
Philippines
|
|
|
|
-
|
26 May 2020
|
26 May 2025
|
| View |
|
DRP-8878
|
Vitamin B-Complex
|
Neurobexol Plus
|
|
Solution for Injection (IM/IV)
|
Prescription Drug (Rx)
|
2 mL USP Type I Amber Glass Ampoule (Box of 10's)
|
Vitamins
|
Nitin Lifesciences Limited
|
India
|
N/A
|
Euro-Health Care Exponents, Inc.
|
Altomed Pharmaceuticals, Inc.
|
Renewal
|
08 August 2022
|
03 October 2027
|
| View |
|
DRP-8878-01
|
Vitamin B-Complex
|
Neurovein
|
Formulation Each 2mL amploule contains:
Thiamine HYdrochloride (Vitamin B1) BP..100mg
Pyridoxine HYdrochloride (Vitamin B5) BP...100mg
Cyanocobalamin (VItamin B12) BP...1000mcg
Nicotinamide BP..100mg
Dexpanthenol BP..50mg
|
Solution For Injection (Im/Iv)
|
Prescription Drug (RX)
|
2mL USP Type I Amber Glass Ampoule (Box of 10's)
|
Vitamin
|
Nitin Lifesciences Ltd.
|
India
|
|
Euro-Health Care Exponents, Inc.
|
Vitalink Health Product Inc.
|
Automatic Renewal
|
22 September 2022
|
03 October 2027
|
| View |
|
DRP-8879
|
Bisacodyl
|
Laxanova
|
5 mg
|
Enteric-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/Opaque White PVC Blister Pack x 10's (Box of 100's)
|
Laxative
|
Saga Laboratories
|
India
|
|
Medinova Pharmaceutical Inc.
|
Medinova Pharmaceutical Inc.
|
Renewal
|
22 March 2023
|
27 May 2028
|
| View |
|
DRP-888
|
Glipizide
|
Glucozide
|
5mg
|
Tablet
|
Prescription Drug (Rx)
|
Blister Pack x 20's (Box of 100's)
|
Oral Hypoglycemic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
|
|
|
Automatic Renewal
|
18 August 2021
|
08 September 2026
|
| View |
|
DRP-888-02
|
Glipizide
|
None
|
5 mg
|
Tablet
|
Prescription Drug (RX)
|
Blister Pack x 20's
|
Oral Hypoglycemic
|
Drugmakers Laboratories, Inc.
|
Philippines
|
|
|
TGP Pharma Inc.
|
Automatic Renewal
|
21 September 2021
|
08 September 2026
|
| View |
|
DRP-8881
|
Ascorbic Acid + Zinc
|
Ascozinc
|
500 mg(Equi. To 568.18mg Sodium Ascorbate)/10 mg (Equi. To 27.5 Sulfate Monohydrate)
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu-Alu Blister Pack x 10's (Box of 30's, 100's and 200's)
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
27 May 2020
|
27 May 2025
|
| View |
|
DRP-8882
|
Cetirizine hydrochloride
|
Zytrex
|
10 mg
|
Film-Coated Tablet
|
Over-The-Counter (OTC)
|
Alu-PVC Blister Pack x 10's (Box of 30's and 100's)
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial (Compliance) (Revalidation)
|
15 March 2022
|
27 May 2025
|
| View |
|
DRP-8883
|
Co-Amoxiclav
|
Augmeed 228.5 DS
|
228.5mg/5mL
|
Powder For Oral Suspension
|
Prescription Drug (RX)
|
HDPE Plastic bottle with 15mL measuring cup x 70mL and 100mL (Box of 1's)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Medopharma Private Limited
|
India
|
|
MedEthix, Inc.
|
MedEthix, Inc.
|
Renewal
|
18 March 2024
|
28 May 2029
|
| View |
|
DRP-8884
|
Co-Amoxiclav
|
Cledomox 228.5 DS
|
228.5mg/5mL
|
Powder For Oral Suspension
|
Prescription Drug (RX)
|
HDPE Plastic bottle with 15mL measuring cup x 70mL and 100mL (Box of 1's)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Medopharma Private Limited
|
India
|
|
MedEthix, Inc.
|
MedEthix, Inc.
|
Renewal
|
13 March 2024
|
28 May 2029
|
| View |
|
DRP-8885
|
Fentanyl (as Citrate)
|
None
|
50mcg/mL
|
Solution For Injection (IV)
|
Prescription Drug (RX)
|
Type I Clear and Colorless glass ampoulee (Box of 10's x 2mL; Box of 10's x 10mL)
|
-
|
Hameln Pharmaceuticals GmbH
|
Germany
|
|
Enlife Global Inc.
|
Enlife Global Inc.
|
-
|
02 July 2020
|
02 July 2025
|
| View |
|
DRP-8886
|
Hydrocortisone
|
Inflazon
|
10mg/g (1%)
|
Lotion
|
Prescription Drug (RX)
|
Opaque White PE Bottle with PP Cap x 30 mL
(Box of l’s)
|
-
|
Interphil Laboratories
|
Philippines
|
|
|
|
-
|
03 December 2020
|
02 July 2025
|
| View |
|
DRP-8886-01
|
Hydrocortisone
|
Eczacort
|
10 mg / g (1%)
|
Lotion
|
Prescription Drug (RX)
|
Opaque white PE bottle with PP cap x 30 mL (Box of 1's)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
|
|
UNILAB, lnc.
|
-
|
07 October 2021
|
02 July 2025
|
| View |
|
DRP-8887
|
Oxaliplatin
|
Staloxa-50
|
2 mg/ mL (50mg/mL)
|
Concentrate Solution for I.V. Infusion
|
Prescription Drug (RX)
|
30mL-capacity USP Type I Amber Moulded Glass Vial x 25mL with bromobutyl rubber stopper and green flip-off seal (Box of 1's)
|
-
|
Admac Lifesciences
|
India
|
Stallion Laboratories Pvt. Ltd.
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial (Correction)
|
20 January 2023
|
02 July 2025
|
| View |
|
DRP-8887-01
|
Oxaliplatin
|
Innoxaplin
|
2 mg/mL (50mg/25mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
30 mL-capacity USP Type I Amber Moulded Glass Vial
x 25 mL with Bromobutyl Rubber Stopper and Green Flip-off Seal (Box of 1's)
|
-
|
Admac Lifesciences
|
India
|
Stallion Laboratories Pvt. Ltd.
|
Ambica International Corporation
|
Innocure Pharma and Medical Supplies Trading
|
Initial (Correction)
|
26 January 2023
|
02 July 2025
|
| View |
|
DRP-8888
|
Oxaliplatin
|
Staloxa-100
|
2 mg/ mL (100mg/50mL)
|
Concentrate Solution for I.V. Infusion
|
Prescription Drug (RX)
|
USP Type I Amber Molded Glass Vial x 50mL with bromobutyl rubber stopper and green flip-off seal (Box of 1's)
|
-
|
Admac Lifesciences
|
India
|
Stallion Laboratories Pvt. Ltd.
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial (Correction)
|
20 January 2023
|
02 July 2025
|
| View |
|
DRP-8888-01
|
Oxaliplatin
|
Innoxaplin 100
|
2 mg/mL
|
Concentrate Solution for IV Infusion
|
Prescription Drug (Rx)
|
USP Type I Amber Molded Glass Vial x 50 mL with bromobutyl rubber stopper and green flip-off seal (Box of 1's)
|
Antioneoplastic agent
|
Admac Lifesciences
|
India
|
N/A
|
Ambica International Corporation
|
Innocure Pharma and Medical Supplies Trading
|
CLIDP Conversion
|
04 October 2022
|
02 July 2025
|