| View |
|
DRP-9179
|
Hyoscine-N-Butylbromide
|
Buscozan
|
10 mg/mL (20 mg/2mL)
|
Solution For Injection (I.M/I.V.)
|
Prescription Drug (RX)
|
Low borosilicate amber glass ampoule in plastic tray
(Box of 10's)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
|
Marzan Pharma Corporation
|
Marzan Pharma Corporation
|
-
|
19 November 2020
|
19 November 2025
|
| View |
|
DRP-9180
|
Enalapril Maleate
|
Benzadiq
|
20 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10 (Box of 30's)
|
-
|
Stallion Laboratories Pvt. Ltd
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial
|
30 September 2020
|
30 September 2025
|
| View |
|
DRP-9181
|
Cefuroxime (as Sodium)
|
Seconxime
|
1.5 g
|
Powder for Injection (I.M./I.V.)
|
Prescription Drug (RX)
|
USP Type I clear glass vial with 20 mm grey bromo butyl rubber stopper sealed with aluminum and green flip-off cap (Box of l’s)
|
-
|
Swiss Parenterals Pvt. Ltd.
|
India
|
BioRx Pharma Labs LLP
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial
|
30 September 2020
|
30 September 2025
|
| View |
|
DRP-9181-01
|
Cefuroxime (as sodium)
|
None
|
1.5 g
|
Powder for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
USP Type I clear glass vial with 20 mm grey bromo butyl rubber stopper sealed with aluminum and green flip-off cap. (Box of 1’s)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Pvt. Ltd
|
India
|
N/A
|
Ambica International Corporation
|
RiteMED Phils., Inc
|
CLIDP Conversion
|
17 November 2023
|
30 September 2025
|
| View |
|
DRP-9182
|
Clarithromycin
|
Biaxin
|
500 mg
|
Lyophized Powder for Injection for I.V.
Infusion
|
Prescription Drug (RX)
|
Type I clear glass vial with grey bromobutyl rubber
stopper and aluminum cap with flip-off seal (Box of l's)
|
Antibacterial (Macrolide)
|
Anfarm Hellas S.S
|
Greece
|
|
Ambicare Pharmaceuticals Inc.
|
Ambicare Pharmaceuticals Inc.
|
Initial
|
30 September 2020
|
30 September 2025
|
| View |
|
DRP-9182-01
|
Clarithromycin
|
None
|
500 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Prescription Drug (Rx)
|
Type I clear glass vial with grey bromobutyl rubber stopper and aluminum cap with flip-off seal (Box of 1's)
|
-
|
Anfarm Hellas S.A.
|
Greece
|
N/A
|
Ambicare Pharmaceuticals Inc
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
CLIDP Conversion
|
29 December 2022
|
30 September 2025
|
| View |
|
DRP-9183
|
Lactulose
|
Stal-Lact
|
3.33 g/5 mL
|
Syrup
|
Prescription Drug (RX)
|
Amber-colored PET bottle sealed with 25 mm PP cap with 10 mL measuring cup x 120 mL (Box of 1's)
|
-
|
Stallion Laboratories Pvt. Ltd
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial
|
30 September 2020
|
30 September 2025
|
| View |
|
DRP-9183-01
|
Lactulose
|
Rifelac
|
3.33 g/5 mL
|
Syrup
|
Prescription Drug (Rx)
|
Amber-colored PET bottle sealed with 25 mm PP cap with mL measuring cup x 120 mL (Box of 1's)
|
Laxative
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Dynasty Pharmaceuticals
|
CLIDP Conversion
|
15 September 2023
|
30 September 2025
|
| View |
|
DRP-9183-02
|
Lactulose
|
Easylooz
|
3.33 g/5 mL
|
Syrup
|
Prescription Drug (Rx)
|
Amber-colored PET bottle sealed with 25 mm PP cap with 10 mL measuring cup x 120 mL (Box of 1's)
|
Laxative
|
Stallion Laboratories Pvt. Ltd
|
India
|
N/A
|
Ambica International Corporation
|
Danzz Pharma Marketing Inc
|
CLIDP Conversion
|
26 November 2023
|
30 September 2025
|
| View |
|
DRP-9183-03
|
Lactulose
|
Laxipate
|
3.33 g / 5 mL
|
Syrup
|
Prescription Drug (Rx)
|
Amber-colored PET bottle sealed with 25 mm PP cap with 10 mL measuring cup x 120 mL / (Box of 1's)
|
Laxative
|
Stallion Laboratories Pvt. Ltd.
|
|
|
Ambica International Corporation
|
The Cathay Drug Co., Inc
|
CLIDP Conversion
|
24 June 2024
|
30 September 2025
|
| View |
|
DRP-9184
|
Celecoxib
|
Brexen
|
200mg
|
Capsule
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
-
|
Zim Laboratories Limited
|
India
|
|
Stangen Pharmaceuticals Philippines Inc.
|
Stangen Pharmaceuticals Philippines Inc.
|
Initial
|
06 October 2020
|
06 October 2025
|
| View |
|
DRP-9190
|
Olanzapine
|
None
|
10 mg
|
Orodispersible tablet
|
Prescription Drug (Rx)
|
Alu Blister pack x 7's (Box of 28's)
|
Antipsychotic
|
Aurobindo Pharma Limited
|
India
|
|
MedEthix, Inc.
|
MedEthix, Inc.
|
Initial
|
01 October 2020
|
01 October 2025
|
| View |
|
DRP-9195
|
Ascorbic Acid + Zinc
|
Per C Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/ Deep Red PVC Blister Pack x 10's (Box of 30's and 100's)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
|
|
|
Renewal
|
17 August 2023
|
02 October 2028
|
| View |
|
DRP-9195-02
|
Ascorbic Acid + Zinc
|
Maxicor Plus
|
500 mg (Equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (Equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 30's and 100's)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
|
|
St. Raphael Archangel Pharmaceutical Product
Distribution
|
Renewal
|
27 July 2021
|
02 October 2028
|
| View |
|
DRP-9195-03
|
Ascorbic Acid + Zinc
|
Star-C
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 100's)
|
Vitamin and Mineral
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
|
|
Jaac Healthline Marketing
|
Automatic Renewal (E-AR)
|
05 November 2023
|
02 October 2028
|
| View |
|
DRP-9195-04
|
Ascorbic Acid + Zinc
|
Zitrin Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent 27.5 mg Zinc Sulfate Monohydrate)
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 100's)
|
Vitamin/ Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
Starpharm, Inc.
|
Automatic Renewal (E-AR)
|
27 October 2023
|
02 October 2028
|
| View |
|
DRP-9195-05
|
Ascorbic Acid + Zinc
|
Muravit Cee Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 30's and 100's)
|
Vitamin/ Mineral
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
N/A
|
N/A
|
Konzept Convenience and Drug Store Corp.
|
Renewal
|
27 October 2023
|
02 October 2028
|
| View |
|
DRP-9195-06
|
Ascorbic Acid + Zinc
|
Glee-C Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 100's)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc
|
India
|
N/A
|
N/A
|
GSP Enterprises
|
Renewal
|
25 January 2024
|
02 October 2028
|
| View |
|
DRP-9195-07
|
Ascorbic Acid + Zinc
|
Selcee Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 30's and 100's)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
St. Raphael Archangel Pharmaceutical Product Distribution
|
Renewal
|
01 June 2022
|
02 October 2028
|
| View |
|
DRP-9195-12
|
Ascorbic Acid + Zinc
|
Curecee Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg
|
|
Over-the-Counter (OTC) Drug
|
Alu/Deep Red PVC Blister Pack x 10's / (Box of 100's)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
|
|
Curecare Pharmaceutical Products Distribution
|
CLIDP Conversion
|
18 February 2024
|
02 October 2028
|