| View |
|
DRP-9637-09
|
Piperacillin (as Sodium) + Tazobactam (as Sodium)
|
Avitam 4.5
|
4g/500mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
30 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green plastic flipoff seal (Box of 1's)
|
Antibacterial (Penicillin/Beta-Lactamase inhibitor)
|
INJECTCARE PARENTERALS PVT. LTD
|
India
|
|
AGLOBAL CARE, INC.
|
MEDHART PHARMA INC.
|
CLIDP Conversion
|
22 December 2022
|
23 April 2026
|
| View |
|
DRP-9638
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Zopian-2.25
|
2 g/250 mg
|
Powder For IV Infusion
|
Prescription Drug (RX)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off plastic seal (Box of 1's)
|
ANTIBACTERIAL (PENICILLIN/BETA-LACTAMASE INHIBITOR)
|
Injectcare Parenterals Pvt Ltd
|
India
|
Antila Lifesciences Pvt. Ltd.
|
Aglobal Care Inc.
|
Aglobal Care Inc.
|
Initial
|
28 February 2022
|
23 April 2026
|
| View |
|
DRP-9638-01
|
Piperacillin (as Sodium) + Tazobactam (as Sodium)
|
Retazollin-2.25
|
2 g/250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III Clear and Colorless Glass Vial Sealed with 20 mm Grey Butyl Rubber Closure and Green Flip-Off Plastic Seal (Box of 1’s)
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
N/A
|
Aglobal Care, Inc.
|
Reta Drug
|
-
|
07 December 2021
|
23 April 2026
|
| View |
|
DRP-9638-02
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
TAZASTAR-2.25
|
2 g/250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III Clear and Colorless Glass Vial Sealed with 20 mm Grey Butyl Rubber Closure and Green Flip-Off Plastic Seal (Box of 1’s)
|
-
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
N/A
|
Aglobal Care, Inc.
|
Redjensons Medical Corporation
|
-
|
09 March 2022
|
23 April 2026
|
| View |
|
DRP-9638-03
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
PITAZOVIN
|
2 g/250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off plastic seal (Box of 1's)
|
ANTIBACTERIAL (PENICILLIN/BETA-LACTAMASE INHIBITOR)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Antila Lifesciences Pvt. Ltd.
|
Aglobal Care, Inc
|
Vintel Med Enterprises
|
-
|
13 June 2022
|
23 April 2026
|
| View |
|
DRP-9638-04
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Berazoba-2.25
|
2g/250mg
|
Powder for IV Infusion
|
Prescription Drug (RX)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off plastic seal (Box of 1's)
|
-
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Antila Lifesciences Pvt. Ltd.
|
Aglobal Care, Inc.
|
Bellus Life Solutions, Inc.
|
CLIDP Conversion
|
17 January 2023
|
23 April 2026
|
| View |
|
DRP-9638-05
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Piptazonob-2.25
|
2 g/250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off seal (Box of 1's)
|
-
|
Injectcare Parenterals Pvt.Ltd.
|
India
|
N/A
|
Aglobal Care, Inc.
|
Gcmed Corp.
|
CLIDP Conversion
|
07 April 2023
|
23 April 2026
|
| View |
|
DRP-9638-06
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazasave- 2.25
|
2 g / 250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off plastic seal (Box of 1's)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Injectcare Parenterals Pvt. Ltd
|
India
|
|
Aglobal Care, Inc
|
Savelink Pharma and Trading Co
|
CLIDP Conversion
|
02 November 2023
|
23 April 2026
|
| View |
|
DRP-9638-07
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Avitam 2.25
|
2 g / 250 mg
|
Powder for IV Infusion
|
Prescription Drug (Rx)
|
20 mL USP Type III clear and colorless glass vial sealed with 20 mm grey butyl rubber closure and green flip-off plastic seal (Box of 1's)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
|
Aglobal Care, Inc.
|
Medhart Pharma Inc
|
CLIDP Conversion
|
05 January 2024
|
23 April 2026
|
| View |
|
DRP-9639
|
Iodine (as Iohexol)
|
Ashexol-300
|
300 mg/mL (equivalent to 647 mg/mL lohexol)
|
Solution For Injection
|
Prescription Drug (RX)
|
100 mL Type I Colorless Transparent Glass Vial (Box of l's and 10's)
|
-
|
Auskorea Pharm Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
JLT Pharma, Inc.
|
-
|
26 April 2021
|
26 April 2026
|
| View |
|
DRP-964
|
Amlodipine (as besilate)
|
Amlomed-5
|
5 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Calcium Channel Blocker
|
Medchem International Limited
|
India
|
|
Pharma-Surrey International, Inc.
|
Pharma-Surrey International, Inc.
|
Automatic Renewal
|
25 January 2023
|
19 February 2028
|
| View |
|
DRP-9640
|
Iodine (as Iohexol)
|
Ashexol 350
|
350 mg/mL (equivalent to 755 mg/mL lohexol)
|
Solution For Injection
|
Prescription Drug (RX)
|
100 mL Type I Colorless Transparent Glass Vial (Box of l's and 10's)
|
-
|
Auskorea Pharm Co., Ltd.
|
Korea
|
|
JLT Pharma, Inc.
|
JLT Pharma, Inc.
|
-
|
26 April 2021
|
26 April 2026
|
| View |
|
DRP-9641
|
Salbutamol (as sulfate) + Guaifenesin + Bromhexine Hydrochloride
|
Ventuss Plus
|
1 mg/ 50 mg/ 2 mg per 5 mL
|
Syrup (Mint Flavor)
|
Prescription Drug (Rx)
|
120 mL Boston Round Amber Bottle with Aluminum cap (Box of 1's)
|
Selective beta-2-adrenoreceptor agonist/ Expectorant/ Mucolytic
|
Scheele Laboratories Phils., Inc.
|
Philippines
|
N/A
|
|
N/A
|
Initial
|
22 April 2021
|
22 April 2026
|
| View |
|
DRP-9642
|
Olanzapine
|
Olandus 5
|
5mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
-
|
Cadila Healthcare Limited
|
India
|
|
Zydus Healthcare Philippines, Inc.
|
Zydus Healthcare Philippines, Inc.
|
Initial (Correction)
|
19 January 2023
|
28 April 2026
|
| View |
|
DRP-9643
|
Zinc
|
Zeenc
|
10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)
|
Film-Coated Tablet
|
Over-The-Counter (OTC)
|
Alu/Clear-PVC/PVDC Blister Pack x 10's
(Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Euro-Health Care Exponents, Inc.
|
|
N/A
|
Initial (OTC)
|
19 April 2021
|
19 April 2026
|
| View |
|
DRP-9644
|
Multivitamins+Iron
|
Multironsaph
|
Formulation Each 5 mL contains: Retinol (Vitamin A)-2500IU Cholecalciferol (Vitamin D3)-400IU Alpha-tocopherol (Vitamin E)-2IU Niacin (Vitamin B3)-10mg Thiamine HCI (Vitamin B1)-5mg Pyridoxine HCI (Vitamin B6)-5mg Riboflavin (Vitamin B2)-2mg Cyanocobalamin (Vitamin B12)-1.5mcg Iron -15 mg (equivalent to 75 mg Ferrous Sulfate)
|
Syrup (Orange Flavor)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
N/A
|
-
|
19 April 2021
|
19 April 2026
|
| View |
|
DRP-9645
|
Ascorbic Acid + Zinc
|
Pedz-Link
|
100 mg/10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate) per 5mL
|
Syrup(Orange Flavor)
|
Over-The-Counter (OTC)
|
Type III Amber Boston Round Glass Bottle Sealed
with Aluminum Screw Cap x 60 mL, 120 mL and 250 mL (Box of l's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vitalink Health Products, Inc.
|
|
N/A
|
Initial (OTC)
|
19 April 2021
|
19 April 2026
|
| View |
|
DRP-9646
|
Ascorbic Acid + Zinc
|
Vitazin - C
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/ 10 mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
Over-The-Counter (OTC)
|
Alu-PVC/PVDC Amber Color Blister Pack x 10's
(Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Ultramed Pharma, Inc.
|
|
N/A
|
Initial (OTC)
|
19 April 2021
|
19 April 2026
|
| View |
|
DRP-9647
|
Paracetamol
|
Parawell-500
|
500 mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Mascot Health Series Pvt. Ltd.
|
India
|
N/A
|
Wellchem Pharmaceutical Product
|
N/A
|
-
|
20 April 2021
|
20 April 2026
|
| View |
|
DRP-9647-01
|
Paracetamol
|
Parachem-500
|
500 mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack of 10's (Box of 100's)
|
Analgesic/Antipyretic
|
Mascot Health Series Pvt. Ltd
|
India
|
N/A
|
Wellchem Pharmaceutical Products
|
Davao Point Pharmaceutical Products
|
-
|
22 March 2022
|
20 April 2026
|