| View |
DRP-11612_PI_01.pdf
|
DRP-11612
|
Dichlorobenzyl alcohol + Amylmetacresol +
Lidocaine hydrochloride
|
Trosoothe Plus
|
1.2 mg/600 mcg/10 mg
|
Lozenge (Honey Lemon
Flavor)
|
Antiseptic/ Anesthetic
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
DRP-11613_PI_01.pdf
|
DRP-11613
|
Dichlorobenzyl alcohol + Amylmetacresol
Lidocaine hydrochloride
|
Trosoothe Plus
|
1.2 mg/600 mcg/10 mg
|
Lozenge (Lemon Flavor)
|
Antiseptic/ Anesthetic
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47893_PI_01.pdf
|
DR-XY47893
|
Tenofovir alafenamide (as fumarate)
|
Tafnat
|
25 mg
|
Film-Coated Tablet
|
Antiviral (Nucleoside/Nucleotide) Reverse Transcriptase Inhibitor)
|
Natco Pharma Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
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DR-XY47906
|
Rivaroxaban
|
Varoxa
|
10 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
-
|
07 April 2022
|
07 April 2027
|
| View |
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DR-XY47905
|
Rivaroxaban
|
Varoxa
|
20 mg
|
Film Coated Tablet
|
Antithrombotic Agent
|
Micro Labs Limited
|
India
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
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DR-XY47876
|
Solifenacin Succinate
|
Urgiso
|
10 mg
|
Film-Coated Tablet
|
Selective M3 Antimuscarinic Receptor Antagonist
|
Micro Labs Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
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DR-XY47877
|
Solifenacin Succinate
|
Urgiso
|
5 mg
|
Film-Coated Tablet
|
Selective M3 Antimuscarinic Receptor Antagonist
|
Micro Labs Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
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DRP-11619
|
Iron (as Ferric hydroxide sucrose complex)
|
Zypiron 20
|
20 mg/mL (100 mg/5 mL)
|
Lyophilized Powder For Injection (Iv)
|
Anti-Anemic
|
Cadila Healthcare Limited
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11598
|
Ascorbic Acid
|
VG RAPCVIT
|
500mg (equivalent to 562.43mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTCPCPR)
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11597
|
Iron + Folic Acid + Cyanocobalamin
|
Venufer
|
41mg (235 mg Ferric Ammonium
71.5mg/50 mcg per 5 mL)
|
Syrup
|
-
|
Sunrise International Labs Limited
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
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DRP-11650
|
Tigecycline
|
Tygepol
|
50 mg
|
Lyophilized Powder for Solution for I.V. Infusion
|
Antibacterial (Tetracycline)
|
Aroma Ilac San. Ltd. Sti.
|
Turkey
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DRP-11512
|
Tigecycline
|
Tigycord 50
|
50 mg
|
Lyophilized Powder for Solution for I.V. Infusion
|
Antibacterial (Tetracycline)
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
DRP-11631_PI_01.pdf
|
DRP-11631
|
Tadalafil
|
Tadafil 20
|
20 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor
|
Hetero Labs Limited
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47884
|
Biotin
|
None
|
5mg
|
Capsule
|
-
|
Solgar, Inc.
|
United States of America
|
Initial [OTCI
|
31 March 2022
|
31 March 2026
|
| View |
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DRP-11572
|
Cefuroxime (as sodium)
|
Seafurox 1500
|
1.5 g
|
Powder for Injection (IM/IV)
|
Second Generation Cephalosporin
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47901
|
Rosuvastatin (as calcium)
|
Rosucol
|
20 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
|
DRP-11516
|
Esomeprazole (as sodium)
|
Quizole
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11659
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Pyrazone-S
|
2 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosphorin-Beta-Lactamase Inhibitor
Combination)
|
NCPC Hebei Huamin Pharmaceutical Co., Limited
|
China
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DRP-11661
|
Propofol
|
Prohab
|
10 mg/mL
|
Emulsion for Injection (I.V.)
|
General Anesthetic
|
Daewon Pharm. Co., Ltd.
|
Korea
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DR-XY47834
|
Paracetamol
|
Paraxam
|
10 mg/mL (1 g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic/Antipyretic (Anilide)
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
01 April 2022
|
01 April 2027
|