| View |
|
DRP-14403
|
Amikacin (as sulfate)
|
Amikate
|
125 mg/mL (250 mg/2 mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14400
|
Ertapenem (as sodium)
|
Ertaject
|
1 g
|
Lyophilized Powder
Powder for Injection (I.M./I.V. Infusion)
|
-
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14466
|
Ampicillin (as sodium)
|
Ampistar 500
|
500 mg
|
Powder for Injection (I.V./I.M.)
|
-
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
08 September 2023
|
08 September 2028
|
| View |
|
DR-XY48879
|
Atropine (as sulfate)
|
None
|
1 mg/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial (Re-application)
|
08 September 2023
|
08 September 2028
|
| View |
|
DRP-14461
|
Paracetamol
|
Parastar IV
|
10 mg/mL
|
Solution for IV Infusion
|
-
|
Eurolife Healthcare Pvt. Ltd
|
India
|
Initial (Correction)
|
25 October 2023
|
08 September 2028
|
| View |
|
DR-XY48867
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
C-Bactum
|
1 g
|
Powder for Injection (IV/IM)
|
-
|
VHB Medi Sciences Ltd
|
India
|
Initial
|
06 September 2023
|
06 September 2028
|
| View |
|
DRP-14446
|
Cefixime (as trihydrate)
|
None
|
200 mg
|
Capsule
|
Antibacterial (Third-generation Cephalosporin)
|
Medico Remedies Limited
|
India
|
Initial (Correction)
|
18 June 2024
|
06 September 2028
|
| View |
|
DRP-14482
|
Propofo
|
Propolyf
|
10 mg/mL (1% w/v)
|
Emulsion for Injection (I.V.)
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
12 September 2023
|
12 September 2028
|
| View |
|
DRP-14496
|
Ketoanalogues+ Essential Amino Acids
|
None
|
Formulation:
Each film-coated tablet contains Calcium-3-methyl-2-oxo-valerate
(a-Ketoanalogue to Isoleucine, calcium salt) Calcium-4-methyl-2-oxo-valerate ........... (a-Ketoanalogue to Leucine, calcium salt) Calcium-2-oxo-3-Phenylpropionate .....
..67 mg
.101 mg
Calcium-DL-2-hydroxy-4(methylthio) butyrate.59 mg (α-hydroxyanalogue to Methionine, calcium salt) L-Lysine acetate USP.
105
mg
.53 mg
L-Threonine USP
23 mg
L-Tryptophan USP
38 mg
30 mg
...68 mg
(o-Ketoanalogue to Phenylalanine, calcium salt) Calcium-3-methyl-2-oxo-butyrate .
(a-Ketoanalogue to Valine, calcium salt)
86 mg
L- Histidine USP
L-Tyrosine USP
|
Film Coated Tablet
|
-
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DRP-14497
|
Ketoanalogues + Essential Amino Acids
|
Aminoket
|
Each film-coated tablet contains Calcium-3-methyl-2-oxo-valerate
.67 mg
...101 mg
(o-Ketoanalogue to Isoleucine, calcium salt) Calcium-4-methyl-2-oxo-valerate. (a-Ketoanalogue to Leucine, calcium salt) Calcium-2-oxo-3-Phenylpropionate .......... (a-Ketoanalogue to Phenylalanine, calcium salt) Calcium-3-methyl-2-oxo-butyrate.
(a-Ketoanalogue to Valine, calcium salt)
..68 mg
,86 mg
Calcium-DL-2-hydroxy-4(methylthio) butyrate.59 mg (a-hydroxyanalogue to Methionine, calcium salt) L-Lysine acetate USP........
L-Threonine USP
L-Tryptophan USP
L- Histidine USP
L-Tyrosine USP
.105 mg
.53 mg
23 mg
..38 mg
30 mg
|
Film Coated Tablet
|
-
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DRP-14451
|
Ketoanalogues + Essential Amino Acids
|
Golamin
|
101 mg/86 mg/68 mg/67 mg/59 mg/105 mg/53 mg/38 mg/30 mg/23 mg
|
FILM COATED TABLET
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
06 September 2023
|
06 September 2028
|
| View |
|
DRP-14452
|
Ketoanalogues + Essential Amino Acids
|
Docket
|
101 mg/86 mg/68 mg/67 mg/59 mg/105 mg/53 mg/38 mg/30 mg/23 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
06 September 2023
|
06 September 2028
|
| View |
|
DRP-14468
|
Atenolol
|
None
|
50 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
08 September 2023
|
08 September 2028
|
| View |
|
DRP-14418
|
Cefixime (as trihydrate)
|
None
|
100 mg
|
Capsule
|
Antibacterial (Third-generation Cephalosporin)
|
Medico Remedies Limited
|
India
|
Initial (Correction)
|
18 June 2024
|
06 September 2028
|
| View |
|
DRP-14483
|
Propofol
|
Profoly
|
10 mg/mL (1% w/v)
|
Emulsion for Injection (I.V.)
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
12 September 2023
|
12 September 2028
|
| View |
|
DRHR-2281
|
Methyl Salicylate + Camphor
|
Kingson
|
4 g (4% w/v)/0.85 g (0.85% w/v) per 100 mL
|
Liniment Oil
|
-
|
Gnocit Pharmaceuticals.
|
Philippines
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
HRP-627
|
Hydroquinone + Tretinoin
|
Trapeel
|
2 g (2% w/v)/ 25 mg (0.025% w/v) per 100 mL
|
Topical Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
05 September 2023
|
05 September 2026
|
| View |
|
DRP-14423
|
Doxofylline
|
Bronchodox
|
400 mg
|
Film-Coated Tablet
|
-
|
Corona Remedies Private Limited
|
India
|
Initial (Re-application)
|
11 September 2023
|
11 September 2028
|
| View |
|
DRP-14421
|
Cisplatin
|
Cisaphtin
|
50 mg
|
Lyophilized Powder for IV Infusion
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
06 September 2023
|
06 September 2028
|
| View |
|
DRP-14438
|
Ascorbic acid + Cholecalciferol (Vitamin D3) + Zinc
|
Xtracee Plus D1000
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
05 September 2023
|
05 September 2028
|