| View |
|
DRP-8514-05
|
Clopidogrel (As Bisulfate)
|
None
|
75mg
|
Film-coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's and 100's)
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Mepro Pharmaceuticals Private Limited
|
India
|
N/A
|
Medethix, Inc.
|
I.E. Medica, Inc.
|
Automatic Renewal
|
06 September 2022
|
22 November 2027
|
| View |
DRP-8515_PI_01.pdf
|
DRP-8515
|
Ketoanalogues + Essential Amino Acids
|
Ketozar
|
101mg, 86mg, 68mg, 67mg, 59mg, 105mg, 53mg, 38mg, 30mg, 23mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Renal Nutrition Therapy
|
Agio Pharmaceuticals Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Renewal
|
01 March 2024
|
24 October 2029
|
| View |
|
DRP-8515-01
|
Ketoanalogues + Essential Amino Acids
|
Unbranded
|
(see reverse for Formulation)
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's Box of 100's
|
Renal Nutrition Therapy
|
Agio Pharmaceuticals Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ritemed Phils., Inc.
|
Renewal
|
01 April 2024
|
24 October 2029
|
| View |
|
DRP-8515-02
|
Ketoanalogues + Essential Amino Acids
|
Ketco
|
Formulation: Each Film-Coated Tablet contains: Calcium-4-methyl-2-oxo-valerate (a-ketoanalogue to leucine, calcium salt)-101mg Calcium-3-methyl-2-oxo-butyrate (a-ketoanalogue to valine, calcium salt)-86mg Calcium-2-oxo-3-phenylpropionate (a-ketoanalogue to phenylalanine, calcium salt)-68mg Calcium-3-methyl-2-oxo-valerate (a-ketoanalogue to isoleucine, calcium salt)-67mg Calcium-DL-2-hydroxy-4-(methylthio) butyrate (a-ketoanalogue to leucine, calcium salt)-59mg L-Lysine Acetate-105mg L-Threonine-53mg L-Histidine-38mg L-Tyrosine-30mg L-Tryptophan-23mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Renal Nutrition Therapy
|
Agio Pharmaceuticals Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
Renewal
|
07 April 2024
|
24 October 2029
|
| View |
|
DRP-8516
|
Irbesartan
|
Virbez 300
|
300 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Opaque white PVC/PVDC Alu Blister Pack x 14's (Box of 28's)
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
|
One Dexcel Pharma Inc.
|
Bell-Kenz Pharma, Inc.
|
Initial (Reconstruction) (Correction)
|
27 February 2024
|
24 October 2024
|
| View |
|
DRP-8516-01
|
Irbesartan
|
Belizar
|
300 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Opaque white PVC/PVDC-Alu Blister Pack x 14's (Box of 28's)
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
N/A
|
One Dexcel Pharma Inc
|
Amediqo Phils., Inc.
|
-
|
16 May 2022
|
24 October 2024
|
| View |
|
DRP-8517
|
Irbesartan
|
Irbexcel-150
|
150 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Opaque white PVC/PVDC-Alu Blister Pack x 14's (Box of 28's)
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
|
One Dexcel Pharma Inc.
|
One Dexcel Pharma Inc.
|
Initial (Reconstruction) (Correction)
|
27 February 2024
|
24 October 2024
|
| View |
|
DRP-8517-01
|
Irbesartan
|
Belizar
|
150 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Opaque white PVC-PVDC-Alu Blister Pack x 14's (Box of 28's)
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
N/A
|
One Dexcel Pharma Inc.
|
Amediqo Phils., Inc.
|
-
|
05 May 2022
|
24 October 2024
|
| View |
|
DRP-8518
|
Cilostazol
|
Cilozol-100
|
100mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Antithrombotic Agent
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Renewal
|
25 April 2024
|
24 October 2029
|
| View |
|
DRP-8519
|
Cilostazol
|
Cilozol-50
|
50mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Antithrombotic Agent
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Renewal
|
26 April 2024
|
24 October 2029
|
| View |
|
DRP-852
|
Loratadine
|
None
|
10 mg
|
Tablet
|
Over-The-Counter (OTC)
|
Aluminum Strip Foil x 10's (Box of 10's)
|
Antihistamine
|
Unique Pharmaceutical Laboratories
|
India
|
|
Ambica International Trading Corporation
|
RiteMed Phils., Inc.
|
Automatic Renewal
|
22 July 2023
|
31 January 2029
|
| View |
|
DRP-852-01
|
Loratadine
|
Lorid
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Aluminum Strip Foil x 10's (Box of 10's)
|
Antihistamine
|
Unique Pharmaceutical Laboratories
|
India
|
|
Ambica International Trading Corporation
|
Diafarm Inc.
|
Renewal
|
20 August 2020
|
31 January 2029
|
| View |
|
DRP-852-03
|
Loratadine
|
Godine
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Aluminum Strip Foil x 10's (Box of 10's)
|
Antihistamine
|
Unique Pharmaceutical Laboratories
|
India
|
|
Ambica International Trading Corporation
|
Applied Pharmaceutical Distribution
|
Renewal
|
20 August 2020
|
31 January 2029
|
| View |
|
DRP-852-04
|
Loratadine
|
Unbranded
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Aluminum Strip Foil x 10's (Box of 10's)
|
Antihistamine
|
Unique Pharmaceutical Laboratories
|
India
|
|
Ambica International Trading Corporation
|
Ambicare Pharmaceuticals, Inc.
|
Renewal
|
15 February 2024
|
31 January 2029
|
| View |
|
DRP-852-05
|
Loratadine
|
Unbranded
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Aluminum Strip Foil x 10's (Box of 10's)
|
Antihistamine
|
Unique Pharmaceutical Laboratories
|
India
|
|
Ambica International Corporation
|
International Pharmaceuticals, Inc.
|
Renewal
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-8521
|
Paracetamol
|
Axapor
|
10mg/Ml (1g/100mL)
|
Solution For I.V. Infusion
|
Prescription Drug (RX)
|
Low Density Polyethylene (LDPE) plastic bottle x 100
mL (net content) (Box of 1's)
|
Analgesic / Antipyretic
|
Axa Parenterals Ltd.
|
India
|
|
Brady Pharma Inc.
|
Brady Pharma Inc.
|
Initial (Reconstruction)
|
12 August 2024
|
25 October 2024
|
| View |
|
DRP-8521-01
|
Paracetamol
|
Sanimol
|
10mg/mL (1g/100mL)
|
Solution for I.V. Infusion
|
Prescription Drug (Rx)
|
Low density Polyethylene (LDPE) plastic bottle x 100 mL (net content). Box of 1's
|
-
|
AXA PARENTERALS LTD.
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Sanimed Pharmaceuticals Inc.
|
Initial
|
29 July 2021
|
25 October 2024
|
| View |
|
DRP-8521-02
|
Paracetamol
|
Paravin
|
10 mg / mL (1 g / 100 mL)
|
Solution For I.V. Infusion
|
Prescription Drug (RX)
|
Low Density Polyethylene (LDPE) plastic bottle x 100 mL (net content) (Box of 1's)
|
-
|
Axa Parenterals Ltd.
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Vintel Med
|
Initial (CLIDP)
|
05 August 2021
|
25 October 2024
|
| View |
|
DRP-8521-03
|
Paracetamol
|
Afreepor
|
10 mg / mL (1 g / 100 mL)
|
Solution For I.V. Infusion
|
Prescription Drug (RX)
|
Low Density Polyethylene (LDPE) plastic bottle x 100 mL (net content). Box of 1's.
|
-
|
AXA Parenterals Ltd.
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp
|
Afree Pharmaceutical Distribution Corp
|
-
|
08 September 2021
|
25 October 2024
|
| View |
|
DRP-8522
|
Losartan Potassium
|
Losaar 50
|
50mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu-PVC/PVdC Blister Pack x 10's (Box of 30's)
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
08 June 2020
|
25 October 2024
|