| View |
|
DRP-9074
|
Cetirizine dihydrochloride
|
Alfree
|
10 mg/ mL
|
Solution (Oral Drops)
|
Over-the-Counter (OTC)
|
Amber PET bottle x 10 mL (Box of 1's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
17 August 2020
|
17 August 2025
|
| View |
|
DRP-9075
|
Citicoline (as sodium)
|
Cognex-500
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Healer's Lab Unit II
|
India
|
|
Raquel-Abbas Pharmaceuticals & General
Merchandise
|
Raquel-Abbas Pharmaceuticals & General
Merchandise
|
-
|
06 May 2021
|
06 May 2026
|
| View |
|
DRP-9075-01
|
Citicoline (as sodium)
|
Citiquest
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 30's)
|
Psychostimulant/Nootropic
|
Healer's Lab (Unit II)
|
India
|
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
Health-Quest Pharma and Medical Supplies Trading
|
CLIDP Conversion
|
27 February 2024
|
06 May 2026
|
| View |
|
DRP-9076
|
Linezolid
|
Lizogold
|
2 mg/mL (600 mg/300 mL)
|
Solution For Iv Injection
|
Prescription Drug (Rx)
|
300 mL LDPE Plastic Bottle (Box of 1's)
|
-
|
AXA PARENTERALS LTD.
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Bliss Pharma Distribution and Consultancy Corp.
|
-
|
15 September 2020
|
15 September 2025
|
| View |
|
DRP-9077
|
Fluticasone Propionate
|
Flutel
|
50 mcg
|
Nasal Spray
|
Prescription Drug (Rx)
|
15 mL Type III Amber glass Bottle with White Plastic 100 mcL spray pump and nsal s[pray applicator equipmentwith LDPE natural Cap ( Box of 1's)
|
-
|
World Medicine Ilac Sanayi Ve Ticaret A.S.
|
Turkey
|
|
Pharma-surrey International,Inc.
|
Pharma-surrey International,Inc.
|
-
|
15 September 2020
|
15 September 2025
|
| View |
|
DRP-9077-01
|
Fluticasone propionate
|
Flumist
|
50 mcg
|
Nasal Spray
|
Prescription Drug (Rx)
|
15 mL Type III Amber Glass Bottle with White Plastic 100 mcL spray pump and nasal spray applicator equipment with LDPE natural cap (Box of 1's)
|
Corticosteroid
|
World Medicine Ilaç Sanayi ve Ticaret A.?
|
Turkey
|
N/A
|
Pharma-Surrey International, Inc
|
Alkem Laboratories Corporation
|
CLIDP Conversion
|
09 June 2022
|
15 September 2025
|
| View |
|
DRP-9078
|
Sitagliptin (as phosphate)
|
Glukex-50
|
50mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial
|
31 October 2020
|
31 October 2025
|
| View |
|
DRP-9078-01
|
Sitagliptin (as phosphate)
|
Gliptadin-50
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s (Box of 30’s)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Medchoice Endocrine Group, Inc.
|
-
|
09 May 2022
|
31 October 2025
|
| View |
|
DRP-9078-02
|
Sitagliptin (as phosphate)
|
None
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Diafarm Inc
|
CLIDP Conversion
|
15 July 2022
|
31 October 2025
|
| View |
|
DRP-9078-03
|
Sitagliptin (as phosphate)
|
Unbranded
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambitech Biopharmaceuticals Inc.
|
CLIDP Conversion
|
15 July 2022
|
31 October 2025
|
| View |
|
DRP-9078-04
|
Sitagliptin (as phosphate)
|
Gliptins
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc
|
CLIDP Conversion
|
29 July 2022
|
31 October 2025
|
| View |
|
DRP-9078-05
|
Sitagliptin (as phosphate)
|
Sitplixin 50
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
CLIDP Conversion
|
09 August 2022
|
31 October 2025
|
| View |
|
DRP-9078-06
|
Sitagliptin (as phosphate)
|
Sitaphil
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Phil Asia Pharma Inc
|
CLIDP Conversion
|
25 August 2022
|
31 October 2025
|
| View |
|
DRP-9079-01
|
Sitagliptin (as phosphate)
|
Gliptadin-100
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Medchoice Endocrine Group, Inc.
|
-
|
16 May 2022
|
31 October 2025
|
| View |
|
DRP-9079-02
|
Sitagliptin (as phosphate)
|
Sitaphil
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Phil Asia Pharma Inc
|
CLIDP Conversion
|
21 July 2022
|
31 October 2025
|
| View |
|
DRP-9079-03
|
Sitagliptin (as phosphate)
|
Gliptins
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
CLIDP Conversion
|
02 August 2022
|
31 October 2025
|
| View |
|
DRP-9079-04
|
Sitagliptin (as phosphate)
|
Sitplixin 100
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
CLIDP Conversion
|
09 August 2022
|
31 October 2025
|
| View |
|
DRP-9079-05
|
Sitagliptin (as phosphate)
|
None
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Diafarm Inc
|
CLIDP Conversion
|
30 August 2022
|
31 October 2025
|
| View |
|
DRP-9079-06
|
Sitagliptin (as phosphate)
|
None
|
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
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Ambitech Biopharmaceuticals Inc.
|
-
|
30 August 2022
|
31 October 2025
|
| View |
|
DRP-9080
|
Esomeprazole (As Magnesium Trihydrate)
|
Esometor 20
|
20 mg
|
Delayed Released Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Proton Pump Inhibitor
|
Pell Tech Health Care Pvt. Ltd.
|
India
|
|
MedEthix Inc.
|
MedEthix Inc.
|
Automatic Renewal
|
28 February 2023
|
22 April 2028
|