| View |
|
DRP-8889
|
Irinotecan Hydrochloride
|
Roteqan
|
20mg/mL
|
Solution for IV Infusion
|
Prescription Drug (RX)
|
5 mL USP Type I Amber Tubular Glass Vial with
bromobutyl omniflex plus coated rubber stopper and light blue aluminum flip-off seal (Box of l’s)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
31 October 2020
|
31 October 2025
|
| View |
|
DRP-8890
|
Ascorbic Acid
|
Stancee
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC/PVDC Blister Pack x 10 (Box of 30's, 100's and 200's)
|
-
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial [OTC] [Revalidation]
|
17 March 2023
|
29 May 2025
|
| View |
|
DRP-8891
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Vispovit-B
|
300 mg/300 mg/1 mg
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial (OTC) [Compliance]
|
31 March 2023
|
29 May 2025
|
| View |
|
DRP-8891-01
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin
(Vitamin B12)
|
Neuromate
|
300 mg/300 mg/1 mg
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Alu Strip Pack x 10's (Box of 30's and 100's)
|
Vitamin
|
Kanion Pharmaceuticals Co., Ltd.,
|
China
|
|
AMB HK Enterprises Inc.
|
Labmate Pharma Inc.
|
Initial CLIDP||Revalidation]
|
07 May 2024
|
29 May 2025
|
| View |
|
DRP-8892
|
Gemcitabine (as hydrochloride)
|
Getabin-200
|
200mg
|
Lyophilized Powder For Intravenous Injection
|
Prescription Drug (RX)
|
USP Type I Transparent Flint Glass Vial with grey rubber stopper and flip-off Aluminum seal (Box of 1's)
|
Antineoplastic Agent
|
Admac Lifesciences
|
India
|
|
Ambica International Corp.
|
Ambica International Corp.
|
Renewal
|
25 July 2024
|
29 May 2030
|
| View |
|
DRP-8893
|
Cefuroxime (as sodium)
|
Unbranded
|
750 mg
|
Powder for Injection (IM/IV)
|
Prescription Drug (Rx)
|
USP Type I Transparent Flint Glass Vial with grey rubber stopper and flip-off Aluminum seal (Box of 1's)
|
Antibacterial (Cephalosporin)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
|
Ambica International Corp.
|
Ambica International Corp.
|
Renewal
|
30 June 2024
|
29 May 2030
|
| View |
|
DRP-8894
|
Gemcitabine (as hydrochloride)
|
Getabin-1000
|
1g
|
Lyophilized Powder For Intravenous Injection
|
Prescription Drug (RX)
|
USP Type I Clear Moulded Glass Vial sealed with 20mm grey bromo butyl rubber stopper and 20mm blue flip-off seal x 50mL (Box of 1's)
|
Antineoplastic Agent
|
Admac Lifesciences
|
India
|
|
Ambica International Corp.
|
Ambica International Corp.
|
Renewal
|
25 July 2024
|
29 May 2030
|
| View |
|
DRP-8895
|
Clarithromycin
|
Clarinova
|
500 mg
|
Powder For Solution For Infusion
|
Prescription Drug (RX)
|
15 ml-capacity USP Type I clear and colorless tubular glass vial stoppered with grey bromobutyl double-slotted rubber stoper along with baby blue aluminum seal (Box of 1's)
|
Antibacterial (Macrolide)
|
Immaculate Lifesciences Private Limited
|
India
|
|
Medinova Pharmaceuticals, Inc.
|
Medinova Pharmaceuticals, Inc.
|
-
|
08 October 2020
|
30 September 2025
|
| View |
|
DRP-8895-01
|
Clarithromycin
|
Gorithro IV
|
500 mg
|
Lyophilized Powder for Solution for Intravenous Infusion
|
Prescription Drug (Rx)
|
15 mL - Capacity USP Type I clear and colorless tubular glass vial stoppered with grey bromobutyl double-slotted rubber stopper along with baby blue aluminum seal (Box of 1's)
|
-
|
Immacule Lifesciences Private Limited
|
India
|
N/A
|
Medinova Pharmaceutical Inc.
|
Go Healthcare Pharmaceutical Distribution
|
CLIDP Conversion
|
07 December 2022
|
30 September 2025
|
| View |
|
DRP-8896
|
Epinephrine
|
BELPHRINE
|
1 mg/mL
|
Solution For Injection (I.M./S.C./I.V. Infusion)
|
Prescription Drug (RX)
|
USP Type I Amber Glass Ampoule x 1mL (Box of 10's)
|
-
|
PT Phapros Tbk.
|
Indonesia
|
|
Bellus Life Solutions, Inc.
|
Bellus Life Solutions, Inc.
|
-
|
09 June 2020
|
09 June 2025
|
| View |
|
DRP-8896-01
|
Epinephrine
|
Adline
|
1 mg/mL
|
Solution for Injection (IM/SC/IV Infusion)
|
Prescription Drug (Rx)
|
USP Type I Amber Glass Ampoule x 1 mL (Box of 10's)
|
Adrenergic (Alpha and Beta-Adrenoreceptor agonist)
|
PT Phapros TBK
|
Indonesia
|
|
Bellus Life Solutions, Inc
|
Phoenix Pharmaceutical, Inc.
|
CLIDP Conversion
|
22 November 2023
|
09 June 2025
|
| View |
|
DRP-8897
|
Olopatadine (as Hydrochloride)
|
Olodin
|
1mg/Ml (0.1% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Prescription Drug (RX)
|
LDPE Plastic bottle with HDPE white screw cap and LDPE nozzle x 5mL (Box of 1's)
|
-
|
FDC Limited
|
India
|
|
Penta Labs Australia (Philippines)
|
Penta Labs Australia (Philippines)
|
-
|
09 June 2020
|
09 June 2025
|
| View |
|
DRP-8898
|
Multivitamins + Iron + Zinc
|
Ferri-C
|
Each Capsule contains: Ascorbic acid (Vitamin C) Folic Acid (Vitamin B,) Cyanocobalamin (Vitamin B12) Iron ( equivalent to 100 mg Iron (III) Hydroxide Polymaltose Complex) Zinc (equivalent to 4 mg Zinc Sulphate Monohydrate)
50 mg 1,5 mg 15 mcg 12.43 mg
1.62 mg
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
|
PhilRx Pharma Inc.
|
PhilRx Pharma Inc.
|
-
|
08 June 2020
|
08 June 2025
|
| View |
|
DRP-8899
|
Multivitamins + minerals
|
Rovitale
|
(See Reverse for formulation)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu-Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
|
PhilRx Pharma Inc.
|
PhilRx Pharma Inc.
|
-
|
08 June 2020
|
08 June 2025
|
| View |
|
DRP-8900
|
Sitagliptin (as phosphate)
|
Unbranded
|
100mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10 (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
Renewal
|
02 August 2024
|
08 June 2030
|
| View |
|
DRP-8900-01
|
Sitagliptin (as phosphate)
|
Unbranded
|
100 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
Neomi Pharmaceuticals Pvt. Ltd.
|
Ambica International Corporation
|
RiteMed Phils., Inc.
|
Renewal
|
12 August 2024
|
08 June 2030
|
| View |
|
DRP-8900-02
|
Sitagliptin (As Phosphate)
|
Gliptadin
|
100 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu blister pack x 10's (Box of 30's)
|
-
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
Neomi Pharmaceuticals Pvt. Ltd.
|
Ambica International Corporation
|
Medchoice Endocrine Group, Inc.
|
-
|
18 November 2021
|
08 June 2025
|
| View |
|
DRP-8900-03
|
Sitagliptin (as phosphate)
|
Astaliptin
|
100 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10 (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Diafarm Inc
|
-
|
24 March 2022
|
08 June 2025
|
| View |
|
DRP-8901
|
Sitagliptin (as phosphate)
|
Unbranded
|
50mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
Renewal
|
01 July 2024
|
08 June 2030
|
| View |
|
DRP-8901-01
|
Sitagliptin (as phosphate)
|
Unbranded
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10 (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ritemed Phils., Inc.
|
Renewal
|
04 August 2024
|
08 June 2030
|