| View |
|
DRP1228-01
|
Purified Water (Distilled Water)
|
None
|
None
|
None
|
-
|
Best Drug Industries, Inc.
|
Philippines
|
-
|
07 March 2022
|
10 October 2025
|
| View |
|
DRP236-04
|
Multivitamins + Iron
|
Medifer
|
(see reverse for formulation)
|
Capsule
|
-
|
LLOYD LABORATORIES, INC.
|
Philippines
|
-
|
10 November 2020
|
19 November 2025
|
| View |
|
DRP4368
|
Levofloxacin (as hemihydrate)
|
Televo
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Quinolone)
|
Zim Laboratories Ltd.
|
India
|
Renewal
|
10 August 2022
|
10 April 2028
|
| View |
|
DRP4450
|
Atorvastatin
|
Brelvastin
|
20mg
|
Film-Coated Tablet
|
-
|
Kausikh Therapeutics (P) Ltd.
|
India
|
-
|
23 November 2020
|
05 June 2025
|
| View |
|
DRP6425-01
|
Esomeprazole (as magnesium trihydrate)
|
Esodime
|
40 mg
|
Tablet
|
-
|
Opsonin Pharma Ltd.
|
Bangladesh
|
-
|
15 December 2020
|
16 February 2025
|
| View |
|
DRP6717-09
|
Omeprazole (As Sodium)
|
Acipraz
|
40mg
|
Lyophilized Powder For IV Injection
|
-
|
ALWIN DMD Pharmaceuticals
|
India
|
-
|
29 July 2021
|
02 June 2026
|
| View |
|
DRP–12209
|
Levocarnitine
|
Lecarnita
|
200 mg/mL (1000 mg/5 mL)
|
Solution for Injection (I.V.)
|
Amino acids and derivatives
|
Help S.A.
|
Greece
|
Initial (Correction)
|
18 October 2022
|
30 June 2027
|
| View |
|
DRXY 44817
|
Aceclofenac
|
None
|
100 mg
|
Film Coated Tablet
|
-
|
Mednext Pharma Pvt Ltd
|
India
|
-
|
18 September 2020
|
04 September 2025
|
| View |
|
DX-XY47479
|
Lacosamide
|
Lacasa 150
|
150 mg
|
Film-Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
-
|
21 October 2021
|
21 October 2024
|
| View |
|
FDA-0564821
|
Capecitabine
|
Pacsita 150
|
150 mg
|
Film-Coated Tablet
|
-
|
Eugia Pharma Specialties Limited Survey
|
India
|
-
|
01 December 2021
|
01 December 2026
|
| View |
|
FDA-0570474
|
Calcium + Zinc + Calcitriol
|
Dcal Vita
|
200mg (equivalent to 500mg Calcium Carbonate) / 7.5mg (equivalent to 20.588mg Zinc Sulfate Monohydrate) / 0.25mcg
|
Softgel Capsule
|
Minerals / Vitamin
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC)
|
19 May 2022
|
19 May 2027
|
| View |
|
FDA-0585399
|
Calcium + Zinc + Calcitriol
|
Dcal Vita
|
200mg (equivalent to 500mg Calcium Carbonate) / 7.5mg (equivalent to 20.588mg Zinc Sulfate Monohydrate) / 0.25mcg
|
Softgel Capsule
|
-
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC) correcttion
|
06 September 2022
|
19 May 2027
|
| View |
|
FDA-0586105
|
Azithromycin(As Dihydrate)
|
Novazith
|
500 mg
|
Film Coated Tablet
|
Antibacterial (Macrolide)
|
AMN Life Pvt. Ltd.
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
FDA-0586564
|
Live Attenuated Infectious Bronchitis (IB) Virus
Vaccine (Vet.)
|
Nobilis IB Primo QX
|
Formulation:
Each dose of contains:
Infectious Bronchitis (IB) Virus (D388 strain)->4 log10 EID50 EID-Embryo Infective Dose
|
Freeze-dried Powder for Injection (Oculo-Nasal/Aerosol)
|
-
|
Merck Sharp & Dohme Animal Health, S.L.
|
Spain
|
Initial
|
22 September 2022
|
22 September 2027
|
| View |
|
FDA-0587624
|
Ezetimibe
|
Exelzio
|
10 mg
|
Tablet
|
-
|
KRKA, d.d., Novo Mesto
|
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
FDA-0587936
|
Amoxicillin (as Trihydrate) (Vet.)
|
Farmaxillin 50
|
50 g per 100 g
|
Powder for Oral Solution
|
-
|
Farmabase Saude Animal Ltda.
|
Brazil
|
Initial (Vet.)
|
11 November 2022
|
11 November 2027
|
| View |
|
FDA-0592541
|
Florfenicol (Vet.)
|
Selectan
|
300mg/mL
|
Solution For Injection (IM)
|
-
|
Laboratorios Hipra S.A.
|
Spain
|
Initial (Vet.)
|
22 May 2023
|
22 May 2028
|
| View |
|
FDA-0592706
|
Tranexamic Acid
|
Armaxenic
|
50mg/mL (250mg/5mL)
|
Solution For Injection (IM/IV)
|
-
|
Union Korea Pharm Co., Ltd
|
Korea
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
FDA-0592800
|
Clonidine hydrochloride
|
Clonisaph-Inf
|
150mcg/mL
|
Solution For Injection (Im/Iv)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
FDA-0596760
|
Menthol Eucalyptus Oil
|
Megascent Herbascent Oil
|
153 mg/42.5 mg per mL
|
Liniment (Orange and
Peppermint Scent)
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
08 March 2024
|
08 March 2026
|