| View |
|
DRP-8994-05
|
Gliclazide
|
Glimcose
|
60 mg
|
Modified Release Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 60's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy
Corporation
|
-
|
25 October 2021
|
14 August 2025
|
| View |
|
DRP-8994-06
|
Gliclazide
|
None
|
60 mg Modified Release Tablet
|
Modified Release Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 60's)
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
TGP Pharma Inc.
|
-
|
07 January 2022
|
14 August 2025
|
| View |
|
DRP-8994-07
|
Gliclazide
|
None
|
60 mg
|
Modified Release Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s (Box of 60's and 100’s)
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc
|
-
|
12 May 2022
|
14 August 2025
|
| View |
|
DRP-8994-08
|
Gliclazide
|
Gliclaphil
|
60 mg
|
Modified Release Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 60's)
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Phil Asia Pharma Inc.
|
CLIDP Conversion
|
25 August 2022
|
14 August 2025
|
| View |
|
DRP-8994-12
|
Gliclazide
|
None
|
60 mg
|
Modified Release Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 60's)
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambitech Biopharmaceuticals Inc
|
CLIDP Conversion
|
01 March 2024
|
14 August 2025
|
| View |
|
DRP-8994-13
|
Gliclazide
|
Glik-S
|
60 mg
|
Modified Release Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 60's)
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Starpharm, Inc
|
CLIDP Conversion
|
11 June 2024
|
14 August 2025
|
| View |
|
DRP-8995
|
Pemetrexed (as disodium hemipentahydrate)
|
Rixanep-100
|
100 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Prescription Drug (RX)
|
USP Type 1 glass vial with grey bromo butyl stopper and aluminum flip off grey color seal (Box of 1's)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
14 August 2020
|
14 August 2025
|
| View |
|
DRP-8996
|
Pemetrexed (as disodium heptahydrate)
|
Pemestal
|
500 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Prescription Drug (RX)
|
USP Type I clear glass vial with 20 mm bromobutyl rubber stopper and 20 mm orange flip-off seal (Box of 1's)
|
-
|
Admac Lifesciences
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
29 July 2020
|
29 July 2025
|
| View |
|
DRP-8996-01
|
Pemetrexed (as disodium heptahydrate)
|
Trexed
|
500 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Prescription Drug (Rx)
|
USP Type I clear glass vial with 20 mm bromobutyl rubber stopper and 20 mm orange flip-off seal (Box of 1's)
|
Antineoplastic (Folic Acid Analogue)
|
ADMAC Lifesciences
|
India
|
N/A
|
Ambica International Corporation
|
Unilab, Inc
|
CLIDP Conversion
|
27 October 2023
|
29 July 2025
|
| View |
|
DRP-8997
|
Gemcitabine (As Hydrochloride)
|
Bligem
|
1 g
|
Lyophilized Powder for Injection (I.V. Infusion)
|
Prescription Drug (RX)
|
Type I tubular clear glass vial with grey butyl rubber plug and green colour flip-off seal (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Bliss Pharma Distribution and Consultancy Corp.
|
-
|
29 July 2020
|
29 July 2025
|
| View |
|
DRP-8999
|
Gemcitabine (As Hydrochloride)
|
Bligem
|
200mg
|
Lyophilized Powder for Injection (I.V. Infusion)
|
Prescription Drug (RX)
|
Type I tubular clear glass vial with grey butyl rubber plug and green colour flip-off seal (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Bliss Pharma Distribution and Consultancy Corp.
|
-
|
29 July 2020
|
29 July 2025
|
| View |
|
DRP-9002
|
Ascorbic Acid + Zinc
|
Gapcee
|
500 mg (Equi. To 568.18 mg Sodium Ascorbate)/ 10 mg (Equi. To 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-The-Counter (OTC)
|
Alu-PVC/PVDC Blister Pack x 10's (Box of 30's, 100's and 200's)
|
Vitamins/Minerals
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
Amb Hk Enterprises Inc.
|
Amb Hk Enterprises Inc.
|
Automatic Renewal
|
09 July 2023
|
30 July 2028
|
| View |
|
DRP-9002-01
|
Ascorbic Acid + Zinc
|
Immumax
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-The-Counter (OTC)
|
Alu-PVC/PVDC Blister Pack x 10's (Box of 30's, 100's and 200's)
|
Vitamin/Mineral
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
N/A
|
AMB HK Enterprises, Inc.
|
West Wing Pharma Sales, Inc.
|
Renewal
|
15 August 2023
|
30 July 2028
|
| View |
|
DRP-9003
|
Domperidone (As Maleate)
|
Emetil-10
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Hiral Labs Limited
|
India
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9004
|
Multivitamins
|
Multilem
|
680IU/200IU/7IU/55mg/18mg/1.6mg/1mg/900mcg/300mcg/3mcg
|
Syrup
|
Over-The-Counter (OTC)
|
Boston Round Amber Bottle with Pilfer Proof
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
|
|
Rilem Pharma Corp.
|
Initial
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9005
|
Multivitamins + Iron
|
None
|
2500IU/400IU/2IU/15mg/10mg/5mg/5mg/2mg/1.8mcg
|
Syrup (Orange Flavor)
|
Over-the-Counter (OTC)
|
Boston Round Amber Bottle with Pilfer Proof Metal Cap x 60mL and 120mL (Box of 1's)
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
|
|
Rilem Pharma Corp.
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9006
|
Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine
|
Sinucalm
|
500mg/25mg/2mg/30mg
|
Tablet
|
Over-the-Counter (OTC)
|
ALU/PVC/PVDC Blister x 10's and 20's (Box of 100's)
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9007
|
Terbinafine (as Hydrochloride)
|
Tenafine
|
10 mg/g (1% w/w)
|
Topical Cream
|
Over-the-Counter (OTC)
|
Aluminum Tube with Cap x 15 g
|
-
|
Dae Hwa Pharmaceutical Co., Ltd.
|
Korea
|
|
Bellus Life Solutions, Inc.
|
Bellus Life Solutions, Inc.
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9008
|
Calcium Carbonate
|
UCAL
|
1.25g (Equivalent to 500mg Elemental Calcium)
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Hiral Labs Limited
|
India
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9008-01
|
Calcium Carbonate
|
Calixarb
|
1.25g (equivalent to 500 mg Elemental Calcium)
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Hiral Labs Limited
|
India
|
|
Aglobal Care, Inc.
|
Bellus Life Solutions, Inc.
|
-
|
10 September 2021
|
03 August 2025
|