| View |
|
DR-XY47721
|
Teicoplanin
|
Vellanin
|
400 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Glycopeptide Antibacterial)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DR-XY47683
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Razonam
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2022
|
31 January 2027
|
| View |
|
DRP-11175
|
Mefenamic Acid
|
None
|
50mg/5mL
|
Oral Suspension
|
Nonsteroidal Anti-inflammatory Drugs (NSAID)
|
Philmed Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DR-XY47722
|
Cefpodoxime (as Proxetil)
|
Cefpo-100
|
100 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
10 February 2022
|
10 February 2027
|
| View |
|
DRP-2858-03
|
Gabapentin
|
Nuropin 300
|
300 mg
|
Capsule
|
Antiepileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Automatic Renewal (E-AR)
|
14 December 2023
|
28 March 2029
|
| View |
|
DRP-11197
|
Sitagliptin (as phosphate monohydrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
11 February 2022
|
11 February 2027
|
| View |
DRP-11158_PI_01.pdf
|
DRP-11158
|
Sitagliptin (as phosphate monohydrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
DRP-11159_PI_01.pdf
|
DRP-11159
|
Sitagliptin (as phosphate monohydrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
DRP-11199_PI_01.pdf
|
DRP-11199
|
Sitagliptin (as Phosphate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
11 February 2022
|
11 February 2027
|
| View |
DRP-11161_PI_01.pdf
|
DRP-11161
|
Sitagliptin (as phosphate monohydrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-11157
|
Sitagliptin (as phosphate monohydrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DR-XY 47704
|
Ibrutinib
|
Imbruvica
|
140 mg
|
Capsule
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Cilag AG
|
Switzerland
|
Monitored Release
|
04 February 2022
|
04 February 2027
|
| View |
|
DR-XY 47705
|
Rosuvastatin (as zinc) + Ezetimibe
|
Rozuor
|
10mg/10mg
|
Capsule
|
-
|
EGIS Pharmaceuticals PLC
|
Hungary
|
-
|
04 February 2022
|
04 February 2027
|
| View |
|
DR-XY 47706
|
Rosuvastatin (as zinc) + Ezetimibe
|
Rozuor
|
20mg/10mg
|
Capsule
|
-
|
EGIS Pharmaceuticals PLC
|
Hungary
|
-
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11138
|
Biperiden Hydrochloride
|
None
|
2mg
|
Tablet
|
Anticholinergic Agent (Tertiary Amine)
|
Life Square Laboratories, Inc.
|
Philippines
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-7597
|
Atorvastatin (As Calcium)
|
Zydusatorva 10
|
10 mg
|
Film-coated Tablet
|
Hmg-Coa Reductase Inhibitor
|
Cadila Healthcare Ltd.
|
India
|
Automatic Renewal
|
24 May 2023
|
06 June 2028
|
| View |
|
DR-XY47714
|
Sultamicillin tosilate
|
Zunamyn
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DRP-11143
|
Tigecycline
|
Tigecid
|
50 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Antibacterial (Tetracycline)
|
Centurion Ilac Sanayi Ve Ticaret A.S.
|
Turkey
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DR-XY47713
|
Sultamicillin tosilate
|
Tamicil
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DR-XY47712
|
Sultamicillin tosilate
|
Sultamin
|
750 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
09 February 2022
|
09 February 2027
|