| View |
|
DRP-12473
|
Pemetrexed (as disodium)
|
Mixeprem
|
500 mg
|
Powder for Solution for IV Infusion
|
Antineoplastic
|
Admac Lifesciences
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DRP-12457
|
Ceftriaxone (as sodium)
|
Novtrix
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-Generation Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DR-XY48296
|
Goserelin (as acetate)
|
Seterus
|
3.6 mg
|
Implant in Pre-filled Syringe for Subcutaneous (SC) Injection
|
-
|
AMW GmbH
|
Germany
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48297
|
Goserelin (as acetate)
|
Seterus
|
10.8 mg
|
Implant in Pre-filled Syringe for Subcutaneous (SC) Injection
|
Gonadotropin Releasing Hormone Analogue
|
AMW GmbH
|
Germany
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DRP-12492
|
Thiamine Mononitrate+ Pyridoxine Hydrochloride +
Cyanocobalamin
|
Vit-3
|
100mg/5mg/50mcg
|
Tablet
|
Vitamins
|
Merit Organics Ltd.
|
India
|
Initial (OTC|PCPR)(Correction)
|
30 September 2022
|
19 August 2027
|
| View |
|
DR-XY48310
|
Pegaspargase
|
Oncaspar
|
750 U/mL
|
Powder for Solution for Injection/ Infusion
(IV/IM)
|
Antineoplastic
|
Lyophilization Services of New England Inc.
|
United States of America
|
Monitored Release
|
23 August 2022
|
23 August 2027
|
| View |
|
DRP-12471
|
Cisplatin
|
Platifirst
|
1 mg/mL (50 mg/50 mL)
|
Solution for Injection for I.V.
Infusion
|
Antineoplastic Agent (Platinum Compound)
|
VHB Medi Sciences Limited
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DR-XY48299
|
Oseltamivir (as phosphate)
|
Tamiselvir
|
75 mg
|
Capsule
|
Antiviral (Neuraminidase Inhibitor)
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12470
|
Ampicillin (As Sodium) + Sulbactam(As Sodium)
|
Lintam
|
500 mg/ 250 mg
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Penicillin / Beta-Lactamase Inhibitor Combination
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DR-XY30665
|
Folic Acid
|
Folinc
|
5 mg
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
18 August 2022
|
21 April 2025
|
| View |
|
HRP-535
|
Hydroquinone + Tretinoin
|
Extrapeel (Exfoliant Solution #1)
|
2g (2% w/v)/ 10mg (0.01% w/v) per 100mL
|
Topical Solution
|
Anti-Acne/Keratolytic/Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
25 July 2024
|
19 August 2029
|
| View |
|
HRP-536
|
Hydroquinone + Tretinoin
|
Extrapeel (Exfoliant Solution #3)
|
2g (2% w/v)/10 mg (0.01% w/v)
|
Topical Solution
|
Anti-Acne/Keratolytic/Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
07 August 2024
|
19 August 2029
|
| View |
|
HRP-538
|
Hydroquinone + Tretinoin
|
Extrapeel (Exfoliant Solution #2)
|
2g (2% w/v)/25mg (0.025% w/v) per 100mL
|
Topical Solution
|
Anti-Acne/Keratolytic/Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
23 August 2024
|
19 August 2029
|
| View |
|
HRP-534
|
Hydroquinone + Tretinoin
|
Extrapeel (Exfoliant Solution #2)
|
2g (2% w/v)/25 mg (0.025% w/v) per 100mL
|
Topical Solution
|
Anti-Acne/Keratolytic/Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
25 July 2024
|
19 August 2029
|
| View |
|
HRP-533
|
Hydroquinone + Tretinoin
|
Extrapeel (Exfoliant Solution #3)
|
2g (2% w/v)/ 25mg (0.025% w/v) per 100mL
|
Topical Solution
|
Anti-Acne/Keratolytic/Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
04 September 2024
|
19 August 2029
|
| View |
DR-XY48307_PI_01.pdf
|
DR-XY48307
|
Nepafenac
|
Optanep
|
3 mg/ mL (0.3% w/v)
|
Sterile Ophthalmic Suspension
|
Non-Steroidal Anti-Inflammatory Drug
|
World Medicine Ilaç Sanayi ve Ticaret A.Ş.
|
Turkey
|
Monitored Release
|
22 August 2022
|
22 August 2027
|
| View |
|
DR-XY48292
|
Carboplatin
|
Carbobil
|
10 mg/mL (450 mg/45 mL)
|
Concentrate for Solution
for Intravenous (IV) infusion
|
Antineoplastic agent
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48294
|
Carboplatin
|
Hexplatin
|
10 mg/mL (150 mg/15 mL)
|
Concentrate for Solution
for Intravenous (IV) Infusion
|
Antineoplastic agent
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48295
|
Carboplatin
|
Carbobil
|
10 mg/mL (150 mg/15 mL)
|
Concentrate for Solution
for Intravenous (IV) Infusion
|
Antineoplastic agent
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48293
|
Carboplatin
|
Carbohex
|
10 mg/mL (450 mg/45 mL)
|
Concentrate for Solution for Intravenous (IV) Infusion
|
Antineoplastic agent
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|