| View |
|
DRP-11687
|
Cefuroxime
|
None
|
500 mg
|
Film Coated Tablet
|
Second Generation Cephalosporins
|
Sance Laboratories Pvt. Ltd.
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DRP-11718
|
Co-Amoxiclav
|
None
|
312.5 mg/5 mL
|
Powder For Suspension
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
21 April 2022
|
21 April 2027
|
| View |
|
DRP-11719
|
Co-Amoxiclav
|
None
|
457 mg per 5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
21 April 2022
|
21 April 2027
|
| View |
|
DR-XY47944
|
Silodosin
|
Ureleve
|
2mg
|
Capsule
|
Alpha-Adrenoreceptor Antagonist
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
19 April 2022
|
19 April 2027
|
| View |
|
DR-XY 47942
|
Daclatasvir (as dihydrochloride)
|
Virdac 30
|
30 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY 47943
|
Daclatasvir (as dihydrochloride)
|
Virdac 60
|
60 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-11685
|
Calcium (as carbonate).
|
None
|
500 mg (equivalent to 1,250 mg Calcium Carbonate)
|
Chewable Tablet
|
Mineral
|
Celogen Generics Pvt. Ltd.
|
India
|
Initial (Reconstruction)
|
30 July 2024
|
27 May 2027
|
| View |
|
DRP-11695
|
Celecoxib
|
Celecophar
|
200 mg
|
Capsule
|
Anti-inflammatory and Anti-rheumatoid product,
Non-steroids (NSAID)
|
Zim Laboratories Limited
|
India
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DRP-11698
|
Doxofylline
|
None
|
200 mg
|
Tablet
|
Bronchodilator
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-11699
|
Doxofylline
|
None
|
400 mg
|
Tablet
|
Bronchodilator
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-11671
|
Doxofylline
|
None
|
100mg/5mL
|
Syrup
|
-
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
11 April 2022
|
11 April 2027
|
| View |
|
DRP-11670
|
Temsirolimus
|
Renacord 30
|
25mg/ml (30mg/1.2ml)
|
Concentrate Solution for IV Infusion
|
-
|
Intas Pharmaceuticals Limited
|
India
|
-
|
11 April 2022
|
11 April 2027
|
| View |
|
DR-XY47935
|
Ranolazine
|
Razine
|
1 g
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47936
|
Ranolazine
|
Razine
|
375 mg
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
DR-XY47938_PI_01.pdf
|
DR-XY47938
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Orange Menthol
Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47939
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Honey Lemon
Menthol Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47940
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Berry Menthol
Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-11505
|
Montelukast (as sodium)
|
Montepro
|
10 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-11500
|
Montelukast (as sodium)
|
Kastel
|
10 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
DR-XY47947_PI_01.pdf
|
DR-XY47947
|
Gemcitabine
|
Gemcilex
|
1 g
|
Powder for Injection (IV)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
20 April 2022
|
20 April 2027
|