| View |
|
DR-XY48759
|
Dopamine Hydrochloride
|
Duomine
|
40mg/mL (200mg /5mL)
|
Solution for Injection (I.V.)
|
-
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48765
|
Atorvastatin (as calcium trihydrate)
|
Crystorvas
|
20mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48766
|
Atorvastatin (as calcium trihydrate)
|
Crystorvas
|
40mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14048
|
Cefuroxime (As Axetil)
|
Cefurogen
|
500mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14047
|
Cefuroxime (As Axetil)
|
Zypraxime
|
500mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
08 June 2023
|
08 June 2026
|
| View |
|
DRP-14052
|
Ketoanalogues and Essential Amino Acids
|
Renotrin
|
Formulation:
Each film coated tablet contains
Calcium-3-methyl-2-oxo-valerate ......67 mg
(a-Ketoanalogue to Isoleucine, calcium salt)
Calcium-4-methyl-2-oxo-valerate.................101 mg
(a-Ketoanalogue to Leucine, calcium salt)
Calcium-2-oxo-3-Phenylpropionate.....68 mg
(a-Ketoanalogue to Phenylalanine, calcium salt)
Calcium-3-methyl-2-oxo-butyrate.............................86 mg
(a-Ketoanalogue to Valine, calcium salt)
Calcium-DL-2-hydroxy-4(methylthio) butyrate...59 mg
(a-hydroxyanalogue to Methionine, calcium salt)
L-Lysine acetate USP. ....105 mg
L-Threonine USP ......53 mg
L-Tryptophan USP .....23 mg
L-Histidine USP ......38 mg
L-Tyrosine USP ......30 mg
Excipients....qs
|
Film-Coated Tablets
|
Renal Nutrition Therapy
|
Globela Pharma Private Limited
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48769
|
Cisatracurium ( As Besilate)
|
Nimbex
|
2 mg/mL
|
Solution for Injcetion (IV)
|
-
|
Aspen SVP (Pty) Ltd.
|
South Africa
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14044
|
Sorafenib Tosylate
|
Livonibe
|
200 mg
|
Film-Coated Tablet
|
-
|
BDR Pharmaceuticals International Pvt. Ltd. - Oncology
Unit
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14017
|
Salbutamol (as sulfate) + Guaifenesin
|
Peesaph-G
|
1mg/50mg per 5mL
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
09 June 2023
|
06 June 2028
|
| View |
|
DRP-14046
|
Cetirizine (as hydrochloride)
|
Pharzin
|
10 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14057
|
Voriconazole
|
Vorica
|
200mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Aspiro Pharma Limited
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14045
|
Cilostazol
|
Clotec
|
50 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-13957
|
Mupirocin
|
Ritol
|
20mg/g (2%w/w)
|
Topical Ointment
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48764
|
Aciclovir
|
Zoylex
|
25mg/mL (250mg/10mL)
|
Solution for IV Infusion
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
FDA-0592800
|
Clonidine hydrochloride
|
Clonisaph-Inf
|
150mcg/mL
|
Solution For Injection (Im/Iv)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14029
|
Pantoprazole (as sodium sesquihydrate) +
Domperidone (as maleate)
|
Pantozisaph
|
40mg/30mg
|
Modified Release Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14062
|
Apixaban
|
Hemapix
|
5 mg
|
Film-Coated Tablet
|
-
|
Sandoz Private Limited
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14061
|
Apixaban
|
Hemapix
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Sandoz Private Limited
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14063
|
Glucose (as monohydrate)
|
Axadex D5
|
5mg/100mL (5% w/v)
|
Solution for IV Infusion
|
-
|
Axa Parenterals Limited.
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
HRP-613
|
Chamomile Oil (Aceite Manzanilla)
|
None
|
1 mL per 100mL (1% v/v)
|
Oil
|
-
|
Ace Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
08 June 2023
|
08 June 2025
|