| View |
|
DR-XY49050
|
Pantoprazole (as sodium)
|
Panzel
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Zee Laboratories.
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-14253
|
Domperidone
|
Abdopen
|
10 mg
|
Film-Coated Tablet
|
Propulsive
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial [OTC]
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15039
|
Sitagliptin (as phosphate) + Metformin Hydrochloride.
|
KoztaTM Plus
|
50 mg/850 mg
|
Film-Coated Tablet
|
Antidiabetic Agent [Dipeptidyl peptidase 4 (DPP-4)
Inhibitor/Biguanide]
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-14251
|
Hydrocortisone + Bacitracin + Polymyxin B Sulfate +
Neomycin
|
Saphcorticin
|
10 mg/ 200 IU/4000 IU/3 mg per g
|
Topical Ointment
|
Antibacterial / Corticosteroid
|
Azine Healthcare Pvt. Ltd
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49044
|
Hydroxyethyl Starch 200/0.5 Sodium Chloride.
|
HES-200
|
30 g/ 4.5 g (200/0.5) per 500 mL
|
Solution for Injection
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|
| View |
|
DR-XY49045
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
30 g/ 4.5 g (130/0.4) per 500 mL
|
Solution for Injection.
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
28 June 2024
|
16 April 2029
|
| View |
|
DR-XY49046
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
15 g/ 2.25 g (130/0.4) per 250 mL
|
Solution for Injection (IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|
| View |
|
DR-XY49038
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/5/12.5
|
160 mg/ 5 mg/ 12.5 mg
|
Film-Coated Tablet.
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49039
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/5/25
|
160 mg/ 5 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial (Correction)
|
15 May 2024
|
16 April 2029
|
| View |
|
DR-XY49040
|
Valsartan Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/10/12.5
|
160 mg/ 10 mg/ 12.5 mg
|
Film-Coated Tablet.
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49041
|
Valsartan Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/10/25
|
160 mg/ 10 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49042
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 320/10/25
|
320 mg/ 10 mg/ 25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB), Other Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DRP-15075
|
Tramadol Hydrochloride + Paracetamol
|
Damadol
|
37.5 mg/325 mg
|
Tablet
|
Opioid in Combination with Non-Opioid Analgesic
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DRP-15076
|
Tramadol Hydrochloride + Paracetamol
|
Rapamol T
|
37.5 mg/325 mg
|
Tablet
|
Opioid in Combination with Non-Opioid Analgesic
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DR-XY49043
|
Glucose + Amino Acids + Electrolytes + Lipids.
|
Nutriflex Omega Special
|
|
Emulsion for Intravenous Infusion
|
Solutions for Parenteral Nutrition
|
B. Braun Melsungen AG
|
Germany
|
Initial
|
16 April 2024
|
16 April 2029
|
| View |
|
DRP-4976-26
|
Cefuroxime (as sodium)
|
Cefuroxx
|
750 mg
|
Powder for Injection (IM/IV)
|
Antibacterial
|
Scott-Edil Advance Research Laboratories & Education Limited
|
India
|
CLIDP Conversion
|
17 March 2024
|
27 November 2028
|
| View |
|
DRP-5052-29
|
Cefixime (As Trihydrate)
|
Cefixstan
|
100 mg/5 mL
|
Granules For Suspension
|
Antibacterial (Third Generation Cephalosporin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
28 March 2024
|
18 August 2027
|
| View |
|
DRP-5102-07
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Gompsul 750
|
500 mg / 250 mg
|
Powder for Injection (IM / IV)
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
China
|
CLIDP Conversion
|
08 March 2024
|
08 February 2026
|
| View |
|
DRP-5407-07
|
Co-Amoxiclav
|
Wellmox 625
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin)
|
Stallion Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
16 March 2024
|
30 July 2029
|
| View |
|
DRP-5429-03
|
Quetiapine (as Fumarate)
|
Qvex
|
25 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Sydler Remedies Pvt. Ltd.
|
India
|
CLIDP Conversion
|
29 March 2024
|
08 August 2029
|