| View |
|
DRP-9314-04
|
Rosuvastatin (as calcium)
|
ControLD 10
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt. Ltd
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Preventia Healthcare Inc.
|
-
|
17 December 2021
|
25 November 2025
|
| View |
|
DRP-9314-05
|
Rosuvastatin (as calcium)
|
Jiaavast-10
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt.Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Jiaa Pharma
|
CLIDP Conversion
|
05 October 2022
|
25 November 2025
|
| View |
|
DRP-9314-06
|
Rosuvastatin (as calcium)
|
Goroztin-10
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals Inc
|
Applied Pharmaceutical Distribution Inc.
|
CLIDP Conversion
|
10 April 2024
|
25 November 2025
|
| View |
|
DRP-9315
|
Rosuvastatin (as calcium)
|
Rosulip-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals, Inc.
|
Suhitas Pharmaceuticals, Inc.
|
-
|
25 November 2020
|
25 November 2025
|
| View |
|
DRP-9315-01
|
Rosuvastatin (as calcium)
|
Rosubet-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt. Limited
|
India
|
|
Suhitas Pharmaceuticals, Inc.
|
BETTER OPTION PHARMACEUTICALS INC>
|
Initial (CLIDP)
|
11 August 2021
|
25 November 2025
|
| View |
|
DRP-9315-02
|
Rosuvastatin (As Calcium)
|
Vastoran-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals, Inc.
|
Orange Biotec Inc.
|
-
|
03 September 2021
|
25 November 2025
|
| View |
|
DRP-9315-03
|
Rosuvastatin (As Calcium)
|
None
|
20 mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals, Inc.
|
Mirabell Medical Corp.
|
Initial (CLIDP)
|
08 October 2021
|
25 November 2025
|
| View |
|
DRP-9315-04
|
Rosuvastatin (as Calcium)
|
Rosucres-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Umedica Laboratories Pvt.Ltd.
|
India
|
|
Suhitas Pharmaceuticals, Inc.
|
HLM PHARMACEUTICAL INC.
|
Initial
|
14 October 2021
|
25 November 2025
|
| View |
|
DRP-9315-05
|
Rosuvastatin (as calcium)
|
ControLD 20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt. Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Preventia Healthcare Inc.
|
-
|
17 December 2021
|
25 November 2025
|
| View |
|
DRP-9315-06
|
Rosuvastatin (as calcium)
|
Jiaavast-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
HMG-CoA Reductase Inhibitor
|
Umedica Laboratories Pvt. Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc
|
Jiaa Pharma
|
CLIDP Conversion
|
04 October 2022
|
25 November 2025
|
| View |
|
DRP-9316
|
Cefuroxime (As Axetil)
|
ZEFUGEN
|
500mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 10's)
|
-
|
Sakar Healthcare Limited
|
India
|
|
Biocare Lifesciences, Inc.
|
Biocare Lifesciences, Inc.
|
-
|
25 November 2020
|
25 November 2025
|
| View |
|
DRP-9317
|
Esomeprazole (Magnesium Trihydrate)
|
Novapraz-40
|
40mg
|
Enteric Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
-
|
ACME Formulation Pvt. Ltd.
|
India
|
|
Medinova Pharmaceutical, Inc.
|
Medinova Pharmaceutical, Inc.
|
-
|
25 November 2020
|
25 November 2025
|
| View |
|
DRP-9317-01
|
Esomeprazole (as magnesium dihydrate)
|
Genprazole
|
40mg
|
Enteric-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/ Alu Blister Pack x 10's (Box of 100's)
|
Proton Pump Inhibitor
|
Acme Formulation Pvt. Ltd.
|
India
|
N/A
|
Medinova Pharmaceutical Inc
|
GA2 Pharmaceutical Inc.
|
CLIDP Conversion
|
31 March 2022
|
25 November 2025
|
| View |
|
DRP-9317-02
|
Esomeprazole (as Magnesium Dihydrate)
|
Eso-eve
|
40 mg
|
Enteric-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Proton Pump Inhibitor
|
Acme Formulation Pvt. Ltd.
|
India
|
N/A
|
Medinova Pharmaceutical Inc.
|
Tri-Eve Pharmaceutical Marketing
|
-
|
29 March 2022
|
25 November 2025
|
| View |
|
DRP-9318
|
Exemestane
|
Exetas 25
|
25mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Opaque White PVC/PVDC-Alu Blister Pack x 10's
(Box of 30's)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
|
Accord Healthcare Limited - Philippine Branch Office
|
|
-
|
14 October 2021
|
14 October 2026
|
| View |
|
DRP-9319
|
Loratadine
|
Loraget
|
10 mg
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Antihistamine
|
Magbro Healthcare Pvt. Ltd.
|
India
|
|
Pharmakon Biotec Inc.
|
Pharmakon Biotec Inc.
|
Initial
|
30 April 2021
|
30 April 2026
|
| View |
|
DRP-932
|
Tramadol Hydrochloride + Paracetamol
|
Cetodol
|
37.5 mg + 325 mg
|
tablet
|
Prescription Drug (RX)
|
Blister Pack
|
Opioid Analgesic /Antipyretic
|
Micor Labs Limited, Unit III
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Automatic Renewal
|
06 December 2022
|
07 March 2028
|
| View |
|
DRP-932-01
|
Tramadol Hydrochloride + Paracetamol
|
Cetra
|
37.5mg/ 325mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10s
|
Opioid Analgesics/ Antipyretics
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Xeno Pharmaceutical Phils. Inc.
|
Automatic Renewal
|
07 March 2023
|
07 March 2028
|
| View |
|
DRP-9320
|
Azithromycin (as dihydrate)
|
Zithrobbas
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 4's (Box of 4's and 20's)
|
Antibacterial (Macrolide)
|
Harmann Pharmaceutical Laboratories (Pvt.) Ltd.
|
Pakistan
|
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
Renewal
|
04 August 2024
|
11 September 2029
|
| View |
|
DRP-9320-01
|
Azithromycin (as dihydrate)
|
Azythrex
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 4's (Box of 4)
|
-
|
Harman Pharmaceutical Laboratories (Pvt.) Ltd.
|
Pakistan
|
|
Rquel-Abbas Pharmaceuticals & General Merchandise
|
EuroAsia Pharmaceuticals, Inc.
|
Initial
|
12 August 2021
|
11 September 2024
|