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BR-1444_PI_01.pdf
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BR-1444
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Tozinameran/Famtozinameran
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Comirnaty Original/Omicron B.A.4-5
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15 mcg/15 mcg/0.3mL
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Dispersion For Injection (IM)
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-
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Pfizer, Inc.
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Belgium
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Monitored Release (MR)
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08 June 2023
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08 June 2028
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HRP-610
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Isopropyl Alcohol
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Alcoplus
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70mL/100mL (70%v/v)
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Topical Solution
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-
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Ocean Deep Industries.
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Philippines
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Initial
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22 May 2023
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22 May 2028
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HRP-609
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Isopropyl Alcohol
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Alcoplus
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70 mL/100mL (70% v/v)
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Topical Solution
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-
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Ocean Deep Industries
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Philippines
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Initial
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22 May 2023
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22 May 2028
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DRP-4812
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Cefoxitin (as sodium)
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Hoxit
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1 g
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Powder For Injection (IM/IV)
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-
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Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd.
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China
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Renewal
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30 May 2023
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11 July 2027
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DRP-13976
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Pantoprazole (As Sodium
Sesquihydrate) + Domperidone
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Panzo-D
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40mg/30mg
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Modified Release Capsule
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-
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Fredun Pharmaceuticals Limited
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India
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Initial
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29 May 2023
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29 May 2028
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DRP-13944
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Colistimethate Sodium
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Colate
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160 mg (equivalent to 2, 000, 000 IU)
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Lyophilized Powder For Injection (I.V.)
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-
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Swiss Parenterals Ltd.
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India
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Initial
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24 May 2023
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24 May 2028
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DRP-13943
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Citicoline Sodium
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Fincoline
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250mg/mL(500mg/2mL)
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Solution for infusion (I.V.)
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-
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Captab Biotec Unit II
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India
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Initial
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23 May 2023
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23 May 2028
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DRP-131947
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5% Dextrose in 0.9% Sodium Chloride
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Sodiko
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5 g/ 900 mg per 100 mL
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Solution For Intravenous Infusion
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-
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Eurolife Healthcare Pvt. Ltd.
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India
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Initial
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23 May 2023
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23 May 2028
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BR-1442
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Oral Poliomyelitis Vaccine (Types 1 and 3)[ Live, Attenuated]
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None
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Formulation:
Each dose of 2 drops (0.1 mL) contains live attenuated poliomyelitis virus (Sabin strain).:
Type 1 ≥106.0CCID50 Type 3 ≥105.8CCID50
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Solution for Oral Administration
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Vaccines
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Serum Institute of India Pvt. Ltd.
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India
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Monitored Release (MR) [Reconstruction]
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07 February 2024
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25 May 2028
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DRP-13979
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Donepezil hydrochloride
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Zypezil Od 10
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10 mg
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Orodispersible Tablet
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-
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Zydus Lifesciences Limited
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India
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Initial
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30 May 2023
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30 May 2028
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DRP-13973
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Atorvastatin Calcium
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Atorimax-20
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20 mg
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Film-Coated Tablet
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-
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Healer's Lab (Unit II)
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India
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Initial
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26 May 2023
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26 May 2028
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| View |
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DRP-13974
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Ampicillin (as sodium)
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Baamcillin-1000
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1 g
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Powder for Injection
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-
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INJECTCARE PARENTERALS PVT LTD.
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India
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Initial
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29 May 2023
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29 May 2028
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| View |
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DRP-13950
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Ceftriaxone (as sodium)
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Cefitrax
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1g
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Powder For Injection (I.M./I.V.)
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-
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Reyoung Pharmaceutical Co., Ltd
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China
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Initial
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24 May 2023
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24 May 2028
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DRP-13949
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Cefixime (as trihydrate)
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Cefinox 400
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400 mg
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Film-Coated Tablet
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-
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Innova Captab Pvt. Ltd.
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India
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Initial
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24 May 2023
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24 May 2028
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| View |
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DR-XY48740
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Roflumilast
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Rafair
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500 mcg
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Tablet
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-
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Zydus Lifesciences Limited
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India
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Initial
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04 May 2023
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24 May 2028
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DRP-13922
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AMlodipine (as besilate)
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Ampress
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10 mg
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Tablet
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-
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Magbro Healthcare Pvt. Ltd.
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India
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Initial
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17 May 2023
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17 May 2028
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| View |
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DRP-13961
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Budesonide
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Budenase 1
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500mcg/ml (1mg/2mL)
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Suspension for Nebulization
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Drug for obstructive airway disease (Glucocorticoid)
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Cipla Limited (Unit 1)
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India
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Initial (Reconstruction).
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24 June 2024
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26 May 2028
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| View |
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DRP-13962
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Budesonide
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Budenase 0.25
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125mcg/mL (0.25 mg/2mL)
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Suspension for Nebulization
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-
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Cipla Limited (Unit I)
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India
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Initial
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26 May 2023
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26 May 2028
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DRP-13945
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Ketoanalogues + Essential Amino Acids
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Ketorex
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Formulation
Each film-coated tablet contains:
Calcium-4-methyl-2-oxo-valerate 101 mg
(a-ketoanalogue to leucine, calcium salt)
L-Lysine Acetate 105 mg
Calcium-3-methyl-2-oxo-butyrate 86 mg
(a-ketoanalogue to valine, calcium salt)
Calcium-2-oxo-3-phenylproprionate 68 mg
(a-ketoanalogue to phenylalanine, calcium salt)
Calcium-3-methyl-2-oxo-valerate 67 mg
(a-ketoanalogue to isoleucine, calcium salt)
Calcium-DL-2-hydroxy-4-(methylthio) butyrate 59 mg
(a-hydroxyanalogue to methionine, calcium salt)
L-Lysine Acetate 105 mg
L-Threonine Acetate 53 mg
L-Histidine 38 mg
L-Tyrosine 30 mg
L-Tryptophan 23 mg
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Film-Coated Tablets
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Renal Nutrition Therapy
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Globela Pharma Private Limited
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India
|
Initial
|
23 May 2023
|
23 May 2028
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| View |
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DRP-13980
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Propanolol Hydrochloride
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Pranol
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10mg
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Tablet
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-
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Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
30 May 2023
|
30 May 2025
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