| View |
|
DRP-10793
|
Isosorbide Mononitrate
|
Saphorbide-60
|
60 mg
|
Prolonged-Release Tablet
|
Vasodilator (Anti-angina)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
24 November 2021
|
24 November 2026
|
| View |
|
DRP-10619
|
Azithromycin (as Dihydrate)
|
Zthrosur-500
|
500 mg
|
Film-Coated Tablet
|
-
|
Theon Pharmaceuticals Ltd.
|
India
|
Initial
|
09 November 2021
|
09 November 2026
|
| View |
|
DR-XY47028
|
Tacrolimus
|
Protopic
|
1 mg/g (0.1%)
|
Ointment
|
-
|
Leo Laboratories Ltd
|
Ireland
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DR-XY47029
|
Tacrolimus
|
Protopic
|
300 mcg/g (0.03%)
|
Topical Ointment
|
-
|
Leo Laboratories Ltd
|
Ireland
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DRP-10761
|
Clindamycin (as Phosphate)
|
Clindacare
|
150 mg/ mL (300 mg/ 2 mL)
|
Solution for Injection
(I.M./I.V.)
|
Antibacterial (Lincosamide)
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
16 November 2021
|
16 November 2026
|
| View |
|
THPR-55
|
Hedera helix L. (Ivy) Leaf
|
V-Lief
|
35mg/5mL
|
Syrup (Cherry Flavor)
|
Traditionally-Used Herbal Product: Helps relieve
productive cough.
|
Ahngook Pharmaceutical Co., Ltd.
|
Korea
|
Initial (OTC)
|
17 November 2021
|
17 November 2026
|
| View |
|
DRP-10797
|
Cholecalciferol (Vitamin D3)
|
None
|
800IU
|
Oral Disintegrating Strips (Strawberry Flavor)
|
Vitamin
|
Zim Laboratories Limited
|
India
|
Initial (OTC)(PCPR)
|
25 November 2021
|
25 November 2026
|
| View |
|
DR-XY47542
|
Pregabalin
|
Valicon
|
75 mg
|
Capsule
|
-
|
Saga Laboratories
|
India
|
-
|
18 November 2021
|
18 November 2026
|
| View |
|
DRP-10746
|
Atorvastatin (as Calcium)
|
Trovipri
|
10 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
15 November 2021
|
15 November 2026
|
| View |
|
DRP-10748
|
Atorvastatin (as Calcium)
|
Trovipri
|
40 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
15 November 2021
|
15 November 2026
|
| View |
|
DRP-10749
|
Atorvastatin (as Calcium)
|
Trovipri
|
80 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
15 November 2021
|
15 November 2026
|
| View |
|
DRP-10747
|
Atorvastatin (as Calcium)
|
Trovipri
|
20 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
15 November 2021
|
15 November 2026
|
| View |
|
DRP-10706
|
Piperacillin (as sodium) + Tazolactam (as sodium)
|
Tazy-4.5
|
4.5 g / 500mg
|
Powder for Injection (IM/IV)
|
-
|
Zhuhai United Laboratories (Zhongshan) Co. Ltd.
|
China
|
Initial (Re-issuance)
|
15 August 2022
|
15 November 2026
|
| View |
|
DRP-10707
|
Piperacillin (as sodium) + Tazolactam (as sodium)
|
Tazy-2.25
|
2.25 g / 250 mg
|
Powder for Injection (IM/IV)
|
-
|
Zhuhai United Laboratories (Zhongshan) Co. Ltd.
|
China
|
Initial (Re-issuance)
|
15 August 2022
|
16 November 2026
|
| View |
|
DR-XY47546
|
Multivitamins + Zinc + Copper
|
Stresstabs Energy Men
|
Formulation: Ascorbic Acid (Vitamin C)-300mg Niacinamide (Vitamin B3)-66mg
Thiamine Mononitrate (Vitamin B1)-33mg dl-Alpha Tocopheryl Acetate (Vitamin E)-30mg Riboflavin (Vitamin B2)-30mg Pantothenic Acid (as Calcium Pantothenate) (Vitamin B5)-20mg Pyridoxine HCl (Vitamin B6)-13.3mg Folic Acid (Vitamin B9)-300mcg Cyanocobalamin (Vitamin B12)-140mcg Biotin (Vitamin B7)-40mcg Lutein-600mcg Zinc (as Oxide)-15mg Copper (as Cupric Sulfate
Anhydrous)-500mcg
|
Film-Coated Tablet
|
-
|
Pfizer Biotech Corporation (Hsinchu Plant)
|
Taiwan
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DRP-10629
|
Sildenafil (As Citrate)
|
Siagra
|
100 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DRP-10627
|
Sildenafil (As Citrate)
|
Robust S
|
100 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
19 November 2021
|
09 November 2026
|
| View |
|
DRP-10709
|
Piperacillin (As Sodium) And Tazobactam (As Sodium)
|
Rezotam
|
2g/250mg
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DRP-10708
|
Piperacillin (As Sodium) + Tazobactam (As Sodium)
|
Rezotam
|
4g/500mg
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DRP-10745
|
Ethambutol Hydrochloride
|
PDR-400
|
400 mg
|
Film-Coated Tablet
|
-
|
Svizera Labs Private Limited
|
India
|
-
|
17 November 2021
|
17 November 2026
|