| View |
|
DRHR-2259
|
Isopropyl Alcohol
|
Uni Alco Safe 2
|
70 mL/100 mL (70% w/w)
|
Topical Solution
|
-
|
Uni elements Enterprises
|
Philippines
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DRHR-2258
|
Isopropyl Alcohol
|
Uni Alco Safe 2
|
70 mL/100 mL (70% w/w)
|
Topical Solution
|
-
|
Uni elements Enterprises
|
Philippines
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DRHR-2260
|
Isopropyl Alcohol
|
Uni Alco Safe 2
|
70 mL/100 mL (70% w/w)
|
Topical Solution
|
-
|
Uni elements Enterprises
|
Philippines
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DRHR-2261
|
Isopropyl Alcohol
|
Uni Alco Safe 2
|
70mL/100mL (70% w/w)
|
Topical Solution
|
-
|
Uni elements Enterprises
|
Philippines
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DR-XY48773
|
Sorafenib (as tosilate)
|
Soravar 200
|
200mg
|
Film Coated Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release
|
13 June 2023
|
13 June 2028
|
| View |
|
BR-1443
|
Factor VIII Inhibitor Bypassing Activity
|
Feiba
|
1000 U/20 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
Blood Coagulation Factors
|
Baxter AG
|
Austria
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
| View |
|
BR-1445
|
Powder for Solution for
Infusion (IV)
|
Feiba
|
2500 U/50 mL (50 U/mL)
|
Powder for Solution for
Infusion (IV)
|
Blood Coagulation Factors
|
Baxter AG
|
Austria
|
Monitored Release
|
19 June 2023
|
19 June 2028
|
| View |
|
DRP-14071
|
Acetylcysteine
|
None
|
600 mg
|
Effervescent Tablet
|
-
|
Vovantis Laboratories Private Limited
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
|
DRP-14069
|
Lisinopril (as dihydrate)
|
Lislin-10
|
10 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14068
|
Lisinopril (as dihydrate)
|
Lislin-20
|
20 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14070
|
Lisinopril (as dihydrate)
|
Lislin-5
|
5 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14072
|
Betamethasone (as valerate)
|
Betasaph
|
1mg/g (0.1% w/w)
|
Cream
|
-
|
Bueno Salud Care (I) Pvt. Ltd.
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
|
DRP-14078
|
Lidocaine Hydrochloride
|
Lidosaph
|
20mg/ml (2% w/v)
|
Solution For Injection (IV)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
15 June 2023
|
15 June 2028
|
| View |
|
DRP-14077
|
Rifampicin + Isoniazid + Ethambutol Hydrochloride + Isoniazid
|
Triosaph
|
150 mg/300 mg/75 mg
|
Film-Coated Tablet
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
15 June 2023
|
15 June 2028
|
| View |
|
DRP-14075
|
soniazid + Pyridoxine Hydrochloride
|
Isosaph-B
|
200 mg/10 mg per 5 mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
india
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DRP-14082
|
Atorvastatin (as calcium trihydrate)
|
Atorix-20
|
20 mg
|
Tablet
|
-
|
Healer's Lab (Unit II)
|
India
|
Initial
|
16 June 2023
|
16 June 2028
|
| View |
|
DRP-14081
|
Amlodipine (as besylate) + Valsartan
|
Ambiforge
|
10mg/160mg
|
Film coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
16 June 2023
|
16 June 2028
|
| View |
|
DR-XY48774
|
Topotecan (as hydrochloride)
|
Toponova
|
2.5mg
|
Powder for Concentrate Solution for Infusion
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
DRP-14067_PI_01.pdf
|
DRP-14067
|
Levothyroxine sodium
|
Thyres 100
|
100 mcg
|
Tablet
|
-
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14065
|
Ceftriaxone (As Sodium)
|
Ceftiros
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|