| View |
|
DRP-10835
|
Iron
|
None
|
105.6mg (equivalent to 325 mg Ferrous Sulfate)
|
Sugar-Coated Tablet
|
Hematinic/Antianemic
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial TOTCPCPR)
|
02 December 2021
|
02 December 2026
|
| View |
|
DRP-10858
|
Lidocaine hydrochloride (as monohydrate)
|
Lydosolv
|
20 mg/mL (2% w/v)
|
Solution for Injection (IV)
|
Local Anesthetic
|
Indoco Remedies Limited
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
DRP-10832_PI_01.pdf
|
DRP-10832
|
Dienogest
|
Vinca
|
2 mg
|
Tablet
|
Progestogen
|
Laboratorios Leon Farma S.A.
|
Spain
|
Initial
|
09 February 2022
|
02 December 2026
|
| View |
|
DRP-10859
|
Ampicillin (As Sodium)
|
Baamcillin-500
|
500 mg
|
Powder for Injection
|
Antibacterial (Penicillin)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DRP-10896
|
Hyoscine-N-Butylbromide
|
Hyocin
|
20 mg/ mL
|
Solution for Injection (IM/IV)
|
Anticholinergic/Anti-spasmodic
|
Sakar Healthcare Pvt. Ltd.
|
India
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
DRP-10831
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine HCI (Vitamin B6) +Cyanocobalamin (Vitamin B12)
|
None
|
100mg/200mg/200mcg
|
Sugar-Coated Tablet
|
-
|
Novagen Healthcare Private Limited
|
India
|
-
|
02 December 2021
|
02 December 2026
|
| View |
|
HMRP-28
|
Plantago ovata Forssk. (Ispaghula husk)
|
Mucilin
|
2.4g/5g
|
Powder For Oral Suspension (ORange Flavor)
|
Herbal Medicine (Bulk-forming Laxative)
|
Berlin Pharmaceutical Industry Co., Ltd.
|
Thailand
|
Initial (from Monitored Release Status)
|
07 December 2021
|
22 February 2026
|
| View |
|
DRP-10860
|
Ampicillin (As Sodium)
|
Baamcillin-250
|
250 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
DRP-10895_PI_01.pdf
|
DRP-10895
|
Ondansetron (as hydrochloride)
|
Ondi
|
2 mg/mL (4 mg/2 mL)
|
Solution for Injection (IM/IV)
|
Antiemetic (5-HT-3-Receptor Antagonist)
|
Sakar Healthcare Pvt. Ltd.
|
India
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
DRP-9905-01
|
Ascorbic Acid + Zinc (as Zinc Ascorbate)
|
Pedia-Vita Plus
|
97.50mg / 9 mg per 5 mL
|
Syrup (Orange Flavor)
|
Vitamin
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
30 August 2022
|
31 August 2027
|
| View |
|
DRP-9195-03
|
Ascorbic Acid + Zinc
|
Star-C
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin and Mineral
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
05 November 2023
|
02 October 2028
|
| View |
|
DRP-10844
|
Paracetamol + Dextromethorphan Hydrobromide +
Phenylephrine Hydrochloride
|
Saphyra-DM
|
325 mg/25 mg/10 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial [OTC] (Correction)
|
14 November 2023
|
06 December 2026
|
| View |
|
DRP-10843
|
Cetirizine Hydrochloride
|
Histasaph-5
|
1 mg/mL (5 mg/5mL)
|
Syrup (Orange Flavor)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10839
|
Cetirizine Hydrochloride
|
Histasaph-OD
|
2.5mg/ml
|
Syrup (Oral Drops) (Orange Flavor)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10841
|
Simethicone
|
Simesaph-OD
|
40mg/ml
|
Suspension (Oral Drops) (Strawberry Flavor)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRHR-2113
|
Sulfur
|
Dr. S Wong's Sulfur Soap (Scented with Moisturizer)
|
2 g per 100 g
|
Soap
|
Antiparasitic/Antifungal
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial [HR]
|
29 December 2021
|
29 December 2026
|
| View |
|
DRP-10816
|
Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride
|
Tuxiril
|
10 mg/5 mg per 10 mL
|
Syrup
|
Antitussive/Nasal Decongestant
|
Medley Pharmaceuticals Limited
|
India
|
Initial (OTC)(PCPR)
|
07 December 2021
|
07 December 2026
|
| View |
|
DRP-5837-04
|
Tramadol Hydrochloride
|
Gentradol
|
50 mg
|
Capsule
|
Opioid Analgesic
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial (Reissuance)
|
29 July 2022
|
26 November 2025
|
| View |
|
DRP-10834
|
Bromhexine Hydrochloride
|
Bromhexsaph
|
4 mg/5 mL
|
Syrup (Raspberry Flavor)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
-
|
03 December 2021
|
03 December 2026
|
| View |
|
DRP-10046-01
|
Pantoprazole (As Sodium Sesquihydrate) + Domperidone
|
Domprix
|
40 mg/ 30 mg
|
Modified Release Capsule
|
-
|
Concept Pharmaceuticals Ltd.
|
India
|
Initial (Variation)
|
14 March 2023
|
17 May 2027
|