| View |
|
DRP-8838-02
|
Levocetirizine Hydrochloride
|
Kaicerine
|
2.5 mg/5 mL
|
Syrup
|
Prescription Drug (RX)
|
Polyetheylene Terephthalate (PET) Amber Bottle
Sealed with Polypropylene Cap x 60mL with 10mL Measuring Cup (Box of 1's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Kaiv Pharmaceutical Product Distribution
|
-
|
03 August 2021
|
02 July 2025
|
| View |
|
DRP-8838-03
|
Levocetirizine hydrochloride
|
Zyvosal
|
2.5 mg / 5 mL
|
Syrup
|
Prescription Drug (Rx)
|
Polyethylene terephthalate (PET) amber bottle sealed with polypropylene cap x 60 mL with 10 mL measuring cup / (Box of 1’s)
|
Antihistamine
|
Stallion Laboratories Pvt. Ltd
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc
|
CLIDP Conversion
|
05 April 2024
|
02 July 2025
|
| View |
|
DRP-8839
|
Adapalene
|
Aknizol
|
1mg/ g (0.1% w/w)
|
Topical Gel
|
Prescription Drug (Rx)
|
Aluminum tube x 15g (Box of 1's)
|
-
|
Agio Pharmaceuticals Ltd.
|
India
|
|
Ambica International Trading Corp
|
Ambica International Trading Corp
|
-
|
02 July 2020
|
02 July 2025
|
| View |
|
DRP-884-01
|
Cefuroxime (As Sodium)
|
Cefugen
|
750mg
|
Powder For Injection
|
Prescription Drug (RX)
|
Clear USP Type II Glass vial with rubber stopper and red flip off-seal
|
Antibacterial
|
Daewon Pharm. Co., Ltd.
|
Korea
|
|
Largen Med., Inc.
|
Southmed Pharma Corporation
|
Automatic Renewal
|
08 December 2022
|
28 September 2027
|
| View |
|
DRP-884-07
|
Cefuroxime (as Sodium)
|
Altoxime
|
750 mg
|
Powder for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
Clear USP Type II Glass Vial with rubber stopper and red flip-off seal (Box of 10's)
|
Antibacterial (Cephalosporin)
|
Daewon Pharm. Co., Ltd.
|
Korea
|
N/A
|
D.B. Manix International, Inc.
|
Altomed Pharmaceuticals, Inc.
|
CLIDP Conversion
|
22 October 2023
|
28 September 2027
|
| View |
|
DRP-884-08
|
Cefuroxime (as Sodium)
|
Medzyme
|
750 mg
|
Powder for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
Clear USP Type II Glass Vial with rubber stopper and red flip-off seal (Box of 10's)
|
Antibacterial (Cephalosporin)
|
Daewon Pharm. Co., Ltd
|
Korea
|
N/A
|
D.B. Manix International, Inc
|
Medhaus Pharma, Incorporated
|
CLIDP Conversion
|
21 November 2023
|
28 September 2027
|
| View |
|
DRP-8840
|
Methylprednisolone (as Sodium Succinate)
|
Ciropred-40
|
40mg
|
Powder For Injection (IM/IV)
|
Prescription Drug (Rx)
|
7.5mL USP Type III Flint glass vial with grey rubber plug and flip-off aluminum seal (Box of 50's)
|
-
|
Ciron Drugs and pharma Pvt. Ltd
|
India
|
|
Biocare Lifesciences Inc.
|
Biocare Lifesciences Inc.
|
-
|
02 July 2020
|
02 July 2025
|
| View |
|
DRP-8841
|
Citicoline (as sodium)
|
Citxl
|
100mg/ mL
|
Syrup
|
Prescription Drug (Rx)
|
60mL in 70mL-capacity amber glass bottle (Box of 1's)
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
02 July 2020
|
02 July 2025
|
| View |
|
DRP-8842
|
Ascorbic Acid
|
Poten-Cee N.A.
|
500mg (Equi. To 562.50mg Sodium ascorbate)
|
Capsule
|
Over-The-Counter (OTC)
|
PVC/PVDC Blister Pack x 10's
|
Vitamin
|
Pascual Laboratories, Inc.
|
Philippines
|
|
|
Pascual Consumer Healthcare Corp.
|
Automatic Renewal
|
04 April 2022
|
11 May 2027
|
| View |
|
DRP-8842-01
|
Ascorbic acid
|
Unbranded
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
PVC/PVDC Blister Pack x 10's Box of 10's, 30's & 100's
|
Vitamin
|
Pascual Laboratories, Inc.
|
Philippines
|
N/A
|
N/A
|
Rose Pharmacy, Incorporated
|
Renewal
|
25 August 2022
|
11 May 2027
|
| View |
|
DRP-8843
|
Ascorbic acid
|
NASCORB
|
500 mg (562.43 mg Sodium ascorbate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 30's and 100's)
|
-
|
Lifesquare Laboratories, Inc
|
Philippines
|
|
|
|
-
|
11 May 2020
|
11 May 2025
|
| View |
|
DRP-8843-01
|
Ascorbic Acid
|
Enhanzee
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Vitamin
|
LifeSquare Laboratories, Inc
|
Philippines
|
N/A
|
N/A
|
Alman Pharmaceuticals, Inc
|
CLIDP Conversion
|
08 July 2022
|
11 May 2025
|
| View |
|
DRP-8843-02
|
Ascorbic Acid
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Vitamin
|
LifeSquare Laboratories, Inc
|
Philippines
|
N/A
|
N/A
|
Novomed Inc
|
CLIDP Conversion
|
07 July 2022
|
11 May 2025
|
| View |
|
DRP-8844
|
Adapalene
|
Ridop
|
1mg/g (0.1%w/w)
|
Topical Gel
|
Prescription Drug (Rx)
|
Lami Tube x 15g (Box of 1's)
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
-
|
15 May 2020
|
15 May 2025
|
| View |
|
DRP-8845
|
Mometasone Furoate
|
Nasative
|
500mcg/mL
|
Nasal Spray Suspension
|
Prescription Drug (Rx)
|
White Opaque PE Bottle with Spray Pump and Actuator Sealed with White PE Shoulder and Closed with Dark Green PP Cap x 18 mL (Box of 1's)
|
-
|
Hanlim Pharmaceutical Co. Ltd.
|
Korea
|
N/A
|
H & B Pharma International, Inc.
|
H & B Pharma International, Inc.
|
Initial (correction)
|
17 March 2023
|
01 December 2025
|
| View |
|
DRP-8845-01
|
Mometasone Furoate
|
Momeclir
|
500 mcg/mL
|
Nasal Spray Suspension
|
Prescription Drug (Rx)
|
White Opaque PE Bottle with Spray Pump and Actuator Sealed with White PE Shoulder and Closed with Dark Green PP Cap x 18 mL (Box of 1’s)
|
-
|
Hanlim Pharmaceutical Co., Ltd
|
Korea
|
N/A
|
H & B Pharma International Inc
|
OEP Philippines, Inc.
|
CLIDP Conversion
|
11 April 2023
|
01 December 2025
|
| View |
|
DRP-8845-02
|
Mometasone Furoate
|
Zymocort
|
500 mcg/mL
|
Nasal Spray Suspension
|
Prescription Drug (Rx)
|
White Opaque PE Bottle with Spray Pump and Actuator Sealed with White PE Shoulder and Closed with Dark Green PP Cap x 18 mL (Box of 1's)
|
Glucocorticoid
|
Hanlim Pharmaceutical Co., Ltd
|
Korea
|
N.A
|
H & B Pharma International Inc
|
The Cathay Drug Co., Inc.
|
CLIDP Conversion
|
21 November 2023
|
01 December 2025
|
| View |
|
DRP-8846
|
Amoxicillin (as trihydrate)
|
MEDOMOX
|
250mg
|
Dispersible Tablets for Oral Suspension
|
Prescription Drug (RX)
|
In box of 2 PVC Blister Pack x 10's
|
-
|
Medo Pharm Private Limited
|
India
|
|
Medethix, Inc.
|
Medethix, Inc.
|
-
|
15 May 2020
|
15 May 2025
|
| View |
|
DRP-8847
|
Amoxicillin (as trihydrate)
|
None
|
250mg
|
Dispersible Tablets for Oral Suspension
|
Prescription Drug (Rx)
|
In box of 2 PVC Blister Pack x 10's
|
-
|
Medo Pharm Private Limited
|
India
|
|
Medethix, Inc.
|
Medethix, Inc.
|
-
|
15 May 2020
|
15 May 2025
|
| View |
|
DRP-8848
|
Risperidone
|
Rispericare
|
1mg/ mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Type III Amber Glass Bottle Sealed with White PP/LDPE Child Resistant with Tamper Evident Cap x 30 mL with Graduated Pipette (Box of 1’s)
|
Antipsychotic
|
Dar Al Dawa Development and Investment Co. Ltd.
|
Jordan
|
Chanelle Medical
|
Ambicare Pharmaceuticals Inc.
|
Ambicare Pharmaceuticals Inc.
|
Renewal
|
23 May 2024
|
15 May 2030
|