| View |
|
DRP-9031
|
Sitagliptin (as Phosphate monohydrate)
|
Sitagli-50
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack of 10's (Box of 30's)
|
-
|
Theon Pharmaceuticals Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
18 August 2020
|
18 August 2025
|
| View |
|
DRP-9032
|
Levetiracetam
|
Klevra
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 50's)
|
-
|
PharmEvo (Pvt.) Limited
|
Pakistan
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
-
|
05 August 2020
|
05 August 2025
|
| View |
|
DRP-9033
|
Levetiracetam
|
Lezure
|
100 mg/mL
|
Oral Solution
|
Prescription Drug (RX)
|
200 mL Type III amber glass bottle with child-resistant
plastic cap x 150 mL + 3 mL-capacity PP oral dosing syringe (Box of 1's)
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
|
Camber Pharmaceuticals, Inc
|
Camber Pharmaceuticals, Inc
|
-
|
04 March 2022
|
20 August 2025
|
| View |
|
DRP-9033-01
|
Levetiracetam
|
IVETRA-100
|
100 mg /mL
|
Oral Solution
|
Prescription Drug (RX)
|
200 mL Type III amber glass bottle with child-resistant
plastic cap x 150 mL + 3 mL-capacity pp oral dosing syringe (Box of 1's)
|
-
|
HETERO LABS LIMITED (UNIT III)
|
India
|
|
CAMBER PHARMACEUTICALS, INC
|
Torrent Pharma Philippines, Inc.
|
-
|
02 March 2022
|
20 August 2025
|
| View |
|
DRP-9033-02
|
Levetiracetam
|
SEIZ OS
|
100mg/mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Type III Amber Glass Bottle with child-resistant plastic cap x 200mL + 3mL - capacity polypropylene oral dosing syringe Box of 1's
|
Antiepileptic
|
Hetero Labs Limited (Unit III)
|
India
|
N/A
|
Camber Pharmaceuticals, Inc.
|
Preventia Healthcare Inc.
|
CLIDP Conversion
|
13 September 2021
|
20 August 2025
|
| View |
|
DRP-9033-03
|
Levetiracetam
|
Lepixa
|
100 mg/mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Type III Amber Glass Bottle with Child-Resistant Plastic Cap x 200 mL + 3 mL-Capacity Polypropylene Oral Dosing Syringe (Box of 1's)
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
N/A
|
Camber Pharmaceuticals, Inc.
|
Emcure Pharma Philippines Inc
|
-
|
21 March 2022
|
20 August 2025
|
| View |
|
DRP-9033-04
|
Levetiracetam
|
Levecare
|
100 mg/mL
|
Oral Solution
|
Prescription Drug (Rx)
|
Type III Amber Glass Bottle with Child-Resistant Plastic Cap x 200 mL + 3 mL - capacity polypropylene oral dosing syringe (Box of 1's)
|
Antiepileptic
|
Hetero Labs Limited (Unit III)
|
India
|
N/A
|
Camber Pharmaceuticals, Inc.
|
Multicare Pharmaceuticals Phils. Inc.
|
CLIDP Conversion
|
29 July 2022
|
20 August 2025
|
| View |
|
DRP-9033-05
|
Levetiracetam
|
Julitam
|
100mg/mL
|
Oral Solution
|
Prescription Drug (Rx)
|
200mL Type III amber glass bottle with child - resistant plastic cap x 150 mL + 3 mL - capacity PP oral dosing syringe (Box of 1's)
|
Antiepileptic
|
Hetero Labs Limited
|
India
|
|
Camber Pharmaceuticals, Inc
|
Zydus Healthcare Philippines Inc
|
CLIDP Conversion
|
22 March 2023
|
20 August 2025
|
| View |
|
DRP-9034
|
Cefepime as (Hydrochloride)
|
Unipime 1g
|
1 g
|
Powder for Injection (I.V./I.M.)
|
Prescription Drug (Rx)
|
USP Type I Borosilicate clear glass vial with grey chlorobutyl rubber stopper sealed with aluminum and orange flip off cap (Box of 10's)
|
-
|
Union Korea Pharm Co., Ltd.
|
Korea
|
|
H & B Pharma International Inc
|
H & B Pharma International Inc
|
Initial (Variation)
|
18 November 2021
|
13 August 2025
|
| View |
|
DRP-9034-01
|
Cefepime (Hydrochloride)
|
Armepime
|
1 g
|
Powder For Injection (IV/IM)
|
Prescription Drug (RX)
|
USP Type 1 Borosilicate Clear Glass Vial with Grey Chlorobutyl Rubber Stopper Sealed with Aluminum and Orange Flip Off Cap (Box of 10's)
|
-
|
Union Korea Pharma Co., Ltd.
|
korea
|
|
H & B International Inc.
|
Pharmaessence Inc.
|
-
|
17 September 2021
|
13 August 2025
|
| View |
|
DRP-9034-02
|
Cefepime (hydrochloride)
|
Centrapime
|
1 g
|
Powder for Injection (I.V./I.M.)
|
Prescription Drug (Rx)
|
USP Type I borosilicate clear glass vial with grey chlorobutyl rubber stopper sealed with aluminum and orange flip off cap (Box of 10's)
|
-
|
Union Korea Pharm. Co., Ltd.
|
Korea
|
N/A
|
H & B Pharma International Inc
|
Central West Medicale Inc
|
CLIDP Conversion
|
14 March 2023
|
13 August 2025
|
| View |
|
DRP-9035
|
Gemcitabine (as Hydrochloride)
|
Gemtex
|
40 mg/ mL
|
Concentrate Solution for Injection for I.V. Infusion
|
Prescription Drug (Rx)
|
Type I Colorless glass vial sealed with grey fluoropolymer coated rubber stopper and aluminum cap x 5mL and 25mL (Box of 1's)
|
-
|
EBEWE Pharma Ges.m.b.H. Nfg. KG
|
Austria
|
|
Sandoz Philippines Corporation
|
|
-
|
05 August 2020
|
05 August 2025
|
| View |
|
DRP-9036
|
Metoprolol Tartrate
|
Myprol
|
50mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Orange PVC Blister pack x 20's (Box of 100's)
|
-
|
New Myrex Laboratories, Inc.
|
Philippines
|
|
|
|
-
|
06 August 2020
|
08 June 2025
|
| View |
|
DRP-9037
|
Aciclovir
|
Cyclostad
|
800 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/White Opaque PVC/PVDC Blister Pack x 5's
|
-
|
STADA Arzneimitte1AG
|
Germany
|
|
STADA Philippines, Inc.
|
STADA Philippines, Inc.
|
Initial (Compliance)
|
07 August 2020
|
07 August 2025
|
| View |
|
DRP-9038
|
Clonazepam
|
Zepaclon
|
2 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Red PVC/PVDC Blister Pack x 10's (Box of 30's)
|
Antiepileptic (Benzodiazepine derivative)
|
Remedica Ltd.
|
Cyprus
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial
|
05 November 2021
|
05 November 2026
|
| View |
|
DRP-9038-01
|
Clonazepam
|
Vermazepine
|
2 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Red PVC/PVDC Blister Pack x 10’s (Box of 30’s)
|
Antiepileptic (Benzodiazepine derivative)
|
Remedica Ltd.
|
Cyprus
|
N/A
|
Ambica International Corporation
|
Verdure Pharmaceuticals Enterprises Inc.
|
CLIDP Conversion
|
13 October 2023
|
05 November 2026
|
| View |
|
DRP-9039
|
Levofloxacin (as lactate)
|
Laxin
|
5 mg/mL (500 mg/100 mL)
|
Solution For IV Infusion
|
Prescription Drug (RX)
|
100 mL Lime Soda lime Glass Infusion Bottle (Box of 1's)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
|
Aglobal Care Inc.
|
Aglobal Care Inc.
|
-
|
18 August 2020
|
18 August 2025
|
| View |
|
DRP-904
|
Clarithromycin
|
Klaz Od
|
500 mg
|
Extended-Release Tablet
|
Prescription Drug (RX)
|
Blister pack x 7's (Box of 70's)
|
-
|
Ind-Swift Limited
|
India
|
|
UNILAB, Inc.
|
UNILAB, Inc.
|
-
|
04 May 2020
|
18 April 2025
|
| View |
|
DRP-9040
|
Diclofenac Sodium
|
F-Diclo
|
25 mg/mL (75 mg/3 mL)
|
Solution For Injection
|
Prescription Drug (Rx)
|
Amber glass bottle w/ gold pilfer proof metal cap
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
|
Aglobal Care Inc.
|
Aglobal Care Inc.
|
Initial
|
24 September 2020
|
24 September 2025
|
| View |
|
DRP-9040-01
|
Diclofenac Sodium
|
Diclocare
|
25 mg/mL (75 mg/3 mL)
|
Solution for Injection (IM/IV)
|
Prescription Drug (Rx)
|
3 mL USP Type Amber Glass Ampoule (Box of 10's)
|
NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
|
Furen Pharmaceutical Group Co. Ltd.
|
China
|
N/A
|
Aglobal Care, Inc.
|
Bellus Life Solutions, Inc.
|
-
|
24 May 2022
|
24 September 2025
|