View |
|
DRP-8895-01
|
Clarithromycin
|
Gorithro IV
|
500 mg
|
Lyophilized Powder for Solution for Intravenous Infusion
|
-
|
Immacule Lifesciences Private Limited
|
India
|
CLIDP Conversion
|
07 December 2022
|
30 September 2025
|
View |
|
DRP-11170-02
|
Fexofenadine hydrochloride
|
Gofenadine
|
180 mg
|
Tablet
|
-
|
Ratnatris Pharmaceuticals Pvt. Ltd
|
India
|
CLIDP Conversion
|
07 December 2022
|
08 February 2027
|
View |
|
DRP-11918-02
|
Dobutamine (as hydrochloride)
|
Dobufree
|
50 mg/mL
|
Solution for Intravenous (I.V.) Infusion
|
-
|
Makcur Laboratories Limited
|
India
|
CLIDP Conversion
|
07 December 2022
|
20 May 2027
|
View |
|
DRP-12041-02
|
Anastrozole
|
Armida
|
1 mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
CLIDP Conversion
|
07 December 2022
|
01 June 2027
|
View |
|
DRP-12583-03
|
Omeprazole (as Sodium)
|
Zolexcel
|
40 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
07 December 2022
|
08 September 2027
|
View |
|
DRP-12666-01
|
Tranexamic Acid
|
Tranexfree
|
100mg/mL (500mg/5mL)
|
Solution for Injection (IV)
|
-
|
Makcur Laboratories Limited
|
India
|
CLIDP Conversion
|
07 December 2022
|
22 September 2027
|
View |
|
DRP-6051-20
|
Ketoanalogues + Essential Amino Acids
|
Ketosential
|
Calcium-4-methyl-2-oxo-valerate (?-ketoanalogue to leucine, calcium salt) 101 mg, Calcium-3-methyl-2-oxo-butyrate (?-ketoanalogue to
valine, calcium salt) 86 mg, Calcium-2-oxo-3-phenylpropionate (?-ketoanalogue to phenylalanine, calcium salt) 68 mg, Calcium-3-methyl-2-oxo-valerate (?-ketoanalogue to isoleucine, calcium salt) 67 mg, Calcium-DL-2-hydroxy-4-(methylthio) butyrate (?- ketoanalogue to methionine, calcium salt) 59 mg, L-Lysine Acetate 105 mg, L-Threonine 53 mg, L-Histidine 38 mg, L-Tyrosine 30 mg, L-Tryptophan 23 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
06 December 2022
|
13 March 2025
|
View |
|
DRP-12263-01
|
Ursodeoxycholic Acid
|
Axialith
|
500 mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
CLIDP Conversion
|
06 December 2022
|
06 July 2027
|
View |
|
DRP-13136
|
Montelukast (as sodium) + Levocetirizine dihydrochloride
|
Stelix
|
10 mg/5 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
PCPR Conversion
|
07 December 2022
|
03 July 2027
|
View |
|
DRP-8137
|
CEFOTAXIME (AS SODIUM)
|
CLADEX
|
1 g
|
Powder For Injection (IM/IV)
|
ANTIBACTERIAL (CEPHALOSPHORIN)
|
PT Dexa Medica
|
Indonesia
|
Renewal
|
16 January 2024
|
25 September 2029
|
View |
|
DRP-13125
|
Tobramycin (as sulfate) + Dexamethasone (as sodium phosphate)
|
Tobracid-DM
|
3mg/1mg per mL
|
Ophthalmic Solution
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
05 December 2022
|
05 December 2027
|
View |
|
DRP-13133
|
Ascorbic Acid
|
Vitceecor C
|
500 mg (Equivalent to 562.4 mg Sodium Ascorbate)
|
Capsule
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
06 December 2022
|
06 December 2027
|
View |
|
DRP-13091
|
Ascorbic Acid + Zinc
|
Totalzee
|
500 mg (equivalent to 562.54 mg Sodium Ascorbate) / 10
mg (equivalent to 27.5 mg Zinc Sulfate)
|
Capsule
|
-
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial (OTC) (Reconstruction)
|
12 January 2024
|
02 December 2027
|
View |
|
DRP-13092
|
Paracetamol + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Neorun
|
325 mg / 25 mg / 2 mg
|
Tablet
|
-
|
Pharmatechnica Laboratory Inc.
|
Philippines
|
Initial [OTC] (Reconstruction)
|
16 January 2024
|
02 December 2027
|
View |
|
DRHR-2169
|
Menthol + Eucalyptus Oil + Camphor
|
Efficascent Boost Pain Relief Massage Roll-On
|
191.60 mg/ 67.06 mg/ 38.32 mg per mL
|
Lotion
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Renewal
|
25 July 2024
|
01 December 2029
|
View |
|
DRHR-2170
|
Methyl Salicylate + Camphor + Menthol
|
Omega Pain Killer Liniment Pro
|
141.90 mg/ 50 mg/ 50 mg per mL
|
Liniment
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Renewal
|
29 June 2024
|
01 December 2029
|
View |
|
DRP-13134
|
Ascorbic Acid + Zinc
|
Ascortain-Z
|
500 mg/ 15 mg
|
Film-Coated Tablet
|
-
|
MMC Healthcare Ltd.
|
India
|
Initial (OTC)
|
06 December 2022
|
06 December 2027
|
View |
|
DRP-13113
|
Miconazole
|
Medizole
|
20mg/g (2% w/w)
|
Topical Cream
|
-
|
S Kant Healthcare Ltd.
|
India
|
Initial (OTC)
|
02 December 2022
|
02 December 2027
|
View |
|
DRP-13090
|
Multivitamins + Minerals
|
None
|
Riboflavin (Vit.B2) (as phosphate sodium)- 0.43 mg
Ascorbic acid (Vitamin C)-1000mg
Tri Basic (Calcium phosphate, Calcium Pantothenate, Phosphorus)..50mg Phosphorous......36mg
Sodium (as a sodium bicarbonate, mono basic sodium phosphate)....65mg Magnesium (as a Magnesium Hydroxide, Magnesium Carbonate)..60mg
Potassium (as Potassium Bicarbonate, Potassium Carbonate, Mono Basic potassium phosphate) -200 mg
Thiamine hydrochloride (Vit.B 1)-0.38mg
Manganese (As Manganese Gluconate)-0.5mg
Folic Acid (Vit.B9).100mcg
Cyanocobalamin (Vitamin B12 ).....25mcg
Chromium (as Chromium Polynicotinate)..10mcg
Vitamin B6 (as pyridoxine hydrochloride) -10mg
Niacinamide (Vit.B3)......4mg
Pantothenic acid (Vit.B5) (as a Calcium pantothenate)-2.5 mg
Zinc (as a Zinc Gluconate)-2 mg .
Excipient
qs.
|
Effervescent Granules (orange Flavor)
|
-
|
Vovantis Laboratories Private Limited
|
India
|
Initial
|
29 November 2022
|
29 November 2027
|
View |
|
DRP-13103
|
Ascorbic Acid +Zinc
|
Jewel-Zee Pro
|
1 g (equivalent to 1.125 g as Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Tablet
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial (OTC)
|
01 December 2022
|
01 December 2027
|