| View |
|
DRMO-106
|
Medical Grade Oxygen
|
None
|
None
|
None
|
Medical Gas
|
Davao Industrial Compressed Gases Corporation.
|
Philippines
|
Initial Rx
|
23 April 2024
|
23 April 2029
|
| View |
|
DRP-15091
|
Vildagliptin + Metformin hydrochloride
|
None
|
50 mg/850 mg
|
Film-Coated Tablet
|
Combination of oral blood glucose lowering drugs
|
Bafna Pharmaceuticals Limited.
|
India
|
Initial
|
22 April 2024
|
22 April 2026
|
| View |
|
DRP-15093
|
Rosuvastatin (as Calcium)
|
Rosuvin 20
|
20 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
PSA Chemicals & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
23 April 2024
|
23 April 2029
|
| View |
|
DR-XY49061
|
Norepinephrine
|
Norepors
|
1 mg/mL
|
Concentrated Solution for I.V. Injection
|
Adrenergic/Dopaminergic Agent
|
Med Biopharma Pvt. Ltd.
|
India
|
Initial Correction]
|
28 May 2024
|
29 April 2029
|
| View |
|
DR-XY49058
|
Pregabalin
|
Prenaxon
|
75 mg
|
Capsule
|
Gabapentinoid
|
Steril-Gene Life Sciences (P) Limited.
|
India
|
Initial (Correction).
|
30 July 2024
|
23 April 2026
|
| View |
|
DR-XY49059
|
Pregabalin
|
Prenaxon
|
150 mg
|
Capsule
|
Gabapentinoid
|
Sterile-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
23 April 2024
|
23 April 2026
|
| View |
|
DRP-15097
|
Metformin hydrochloride
|
Gluventa PR 1000
|
1 g
|
Prolonged-Release Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Inventia Healthcare Limited
|
India
|
Initial
|
29 April 2024
|
29 April 2029
|
| View |
|
DRP-15098
|
Metformin hydrochloride
|
Gluventa PR 500
|
500 mg
|
Prolonged-Release Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Inventia Healthcare Limited
|
India
|
Initial
|
29 April 2024
|
29 April 2029
|
| View |
|
DR-XY49060
|
Milrinone (as lactate)
|
Milronex
|
1 mg/mL (10 mg/10 mL)
|
Solution for Injection (IV)
|
Phosphodiesterase Inhibitor
|
United Biotech Pvt. Ltd.
|
India
|
Monitored Release
|
29 April 2024
|
29 April 2029
|
| View |
|
DRP-14523
|
Co-Amoxiclav
|
Clavoxsea 1000
|
1 g
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial (Correction)
|
29 September 2023
|
02 June 2027
|
| View |
|
DRHR-2167
|
Menthol + Eucalyptus Oil
|
Vaporin Pain Relief Balm
|
380 mg / 50 mg per gram
|
None
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial (HR)
|
24 November 2022
|
24 November 2024
|
| View |
|
DRP-13192
|
Fusidic Acid
|
Usidin 2%
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antibacterial
|
Pacific Pharmaceuticals Ltd.
|
Pakistan
|
Initial (OTC)
|
22 December 2022
|
22 December 2027
|
| View |
|
DRP-12981
|
Magnesium Sulfate
|
none
|
250 mg/mL
|
Solution for Injection (I.M./I.V.)
|
Anticonvulsant
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 November 2022
|
18 November 2027
|
| View |
|
DRP-13507-02
|
Azithromycin (as dihydrate)
|
Retamxcin
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
S Kant Healthcare Limited
|
India
|
CLIDP Conversion
|
05 January 2024
|
02 March 2028
|
| View |
|
DRP-13507-03
|
Azithromycin (as dihydrate)
|
Azicass
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
S Kant Healthcare Limited
|
India
|
CLIDP Conversion
|
14 February 2024
|
02 March 2028
|
| View |
|
DRP-13507-04
|
Azithromycin (as dihydrate)
|
Gozithro
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
S KANT HEALTHCARE LIMITED
|
India
|
CLIDP Conversion
|
24 April 2024
|
02 March 2028
|
| View |
|
DRP-5930-12
|
Omeprazole Sodium
|
Omesave
|
40 mg
|
Lyophilized Powder for Injection
|
Proton Pump Inhibitor
|
FUREN PHARMACEUTICAL GROUP CO., LTD
|
China
|
CLIDP Conversion
|
06 February 2024
|
05 December 2028
|
| View |
|
DRP-11334-05
|
Co-Amoxiclav
|
Retaclav
|
457 mg/5 mL
|
Powder for Oral Suspension (see reverse for formulation)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
MEDOPHARM PRIVATE LIMITED
|
India
|
CLIDP Conversion
|
20 December 2023
|
02 March 2027
|
| View |
|
DRP-11334-06
|
Co-Amoxiclav
|
Clavsave-457
|
457 mg / 5mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Medopharm Private Limited
|
India
|
CLIDP Conversion
|
20 December 2023
|
02 March 2027
|
| View |
|
DRP-9638-06
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazasave- 2.25
|
2 g / 250 mg
|
Powder for IV Infusion
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Injectcare Parenterals Pvt. Ltd
|
India
|
CLIDP Conversion
|
02 November 2023
|
23 April 2026
|