| View |
|
DRP-13558
|
Lapatinib (as distosylate monohydrate)
|
Lapaheal
|
250 mg
|
Film-Coated Tablet
|
-
|
BDR Pharmaceuticals International Pvt. Ltd.Oncology Unit
|
India
|
Initial (Correction)
|
29 September 2023
|
09 March 2028
|
| View |
|
DRP-13561
|
Anastrozole
|
Anasoma 1
|
1 mg
|
Film Coated Tablet
|
-
|
Eugia Pharma Specialties Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13562
|
Anastrozole
|
None
|
1 mg
|
Film Coated Tablet
|
-
|
Eugia Pharma Specialties Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13572
|
Acyclovir
|
Saphrivax - 200
|
200mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
10 March 2023
|
10 March 2028
|
| View |
|
DR-XY48657
|
Escitalopram (as oxalate)
|
Ciklox
|
20 mg
|
Film-Coated Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 March 2023
|
17 March 2028
|
| View |
|
DR-XY48644
|
Ketoconazole
|
Kezole
|
20mg/g (2% w/w)
|
Topical Cream
|
Antifungal (Imidazole and Triazole)
|
Zee Laboratories Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13615
|
Paracetamol + Tramadol Hydrochloride
|
Aradol
|
325 mg/37.5 mg
|
Effervescent Tablet
|
-
|
Vovantis Laboratories Private Limited
|
India
|
Initial
|
17 March 2023
|
17 March 2028
|
| View |
|
DRP-13613
|
Paracetamol + Orphenadrine Citrate
|
Acedrine
|
650mg/ 50mg
|
Tablet
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
21 March 2023
|
21 March 2025
|
| View |
DRP-13550_PI_01.pdf
|
DRP-13550
|
Ketorolac Tromethamine
|
Kerola
|
30mg/mL
|
Solution for Injection (IV/IM)
|
-
|
Dai Han Pharm. Co., Ltd.
|
Korea
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13585
|
Levetiracetam
|
Levetramed - 500
|
500 mg
|
Film-Coated Tablet
|
-
|
Zhejiang Jingxin Pharmaceutical Co. Ltd.
|
China
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13584
|
Levetiracetam
|
Levetramed - 1000
|
1 g
|
Film-Coated Tablet
|
-
|
Zhejiang Jingxin Pharmaceutical Co. Ltd.
|
China
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13587
|
Moxifloxacin (as Hydrochloride)
|
Opthomox
|
5 mg/mL (0.5% w/v)
|
Sterile Ophthalmic Solution.
|
-
|
Indiana Ophthalmics
|
India
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13551
|
Sterile Water For Injection
|
None
|
10mL
|
Solution for Injection
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13583
|
Latanoprost
|
Novaprost
|
50 mcg/mL (0.005% w/v)
|
Ophthalmic Solution
|
-
|
Pharmacos Exakta, S.A. de C.V.
|
Mexico
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
HRP-574
|
Menthol + Camphor
|
CoolStick
|
940 mg/15 mg per gram
|
Liniment Stick
(Eucalyptus Scent)
|
-
|
Marklene Fabricate Corp.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2025
|
| View |
|
HRP-575
|
Menthol + Camphor
|
CoolStick
|
940 mg/15 mg per gram
|
Liniment Stick
(Orange Scent)
|
-
|
Marklene Fabricate Corp.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2025
|
| View |
|
HRP-576
|
Menthol + Camphor
|
CoolStick
|
940 mg/15 mg per gram
|
Liniment Stick (Lavender Scent)
|
-
|
Marklene Fabricate Corp.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2025
|
| View |
|
DRP-13625
|
Paracetamol
|
Saphramol Inj-150
|
10mg/mL
|
Solution For IV Infusion
|
-
|
Jedux Parenteral Private Limited
|
India
|
Initial
|
20 March 2023
|
20 March 2028
|
| View |
|
DRP-13549
|
Gabapentin
|
Gaba-P300
|
300 mg
|
Capsule
|
-
|
The Madras Pharmaceuticals
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13606
|
Tobramycin (as Sulfate)
|
Tobrazin
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution (Drops)
|
Antibacterial (Aminoglycoside)
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
16 March 2023
|
16 March 2028
|