| View |
|
DRP-14060
|
Citicoline (as sodium)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14018
|
Hypromellose
|
Hyper-Moist
|
3mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Eye Lubricant
|
Axa Parenterals Limited
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
06 June 2028
|
| View |
|
DRP-14020
|
Losartan Potassium + Hydrochlorothiazide
|
Combizar
|
100 mg/25 mg
|
Film-Coated Tablet
|
-
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14053
|
Paclitaxel
|
Taxaica-30
|
6mg/mL (30mg/5mL)
|
Concentrate For Solution For Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14024
|
Enalapril Maleate
|
None
|
10 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14051
|
Levocetirizine Dihydrochloride
|
Levosaphzine-5
|
5 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2026
|
| View |
|
DRP-14043
|
Betamethasone ( as dipropionate)
|
Novthasone
|
0.05% w/w
|
Topical Cream
|
-
|
S Kant Healthcare Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48768
|
Tioconazole + Tinidazole
|
Tiotin
|
100 mg/ 150 mg
|
Vaginal Soft Gel capsule
|
-
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14025
|
Anastrozole
|
Castra 1
|
1 mg
|
Film-Coated Tablet
|
-
|
Zydus Lifesciences Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14050
|
Ketoanalogues + Essential Amino Acids
|
Ketorex
|
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
(α-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 Tablet
|
Renal Nutrition Therapy
|
Globela Pharma Private Limited
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14049
|
Omeprazole
|
None
|
20 mg
|
Capsule
|
-
|
Medico Remedies Limited
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14056
|
Norepinephrine
|
Noremarc 8
|
1mg/mL (8mg/8mL)
|
Concentrate Solution For Infusion (I.V.)
|
-
|
HBM Pharma S.R.O
|
Slovak Republic
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14023
|
Clotimazole
|
Candigo
|
10mg/g (1% w/w)
|
Cream
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14021
|
Tranexamic Acid
|
Hemarife
|
100 mg/mL
|
Solution For Injection (IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48760
|
Olmesartan Medoxomil
|
Alzor
|
40mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48761
|
Olmesartan Medoxomil
|
Alzor
|
20mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48770
|
Tramadol Hydrochloride + Paracetamol
|
Dolcet Mini
|
18.75/162.50 mg
|
Film-Coated Tablet
|
-
|
Handok Inc.
|
Korea
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
FDA-0592706
|
Tranexamic Acid
|
Armaxenic
|
50mg/mL (250mg/5mL)
|
Solution For Injection (IM/IV)
|
-
|
Union Korea Pharm Co., Ltd
|
Korea
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14019
|
Co-Amoxiclav
|
Comxicla
|
457 mg/5 mL
|
Powder For Suspension
|
-
|
Indchemie Health Specialities Private Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14016
|
Atracurium Besylate
|
Tracrium
|
10 mg/mL
|
Solution for Injection (IV)
|
-
|
Aspen SVP (Pty) Ltd.
|
Africa
|
Initial (Correction)
|
09 August 2023
|
09 June 2028
|