| View |
|
DRP-4670-02
|
Spironolactone
|
Spirodix-100
|
100 mg
|
Tablet
|
Diuretic
|
Unicure Remedies Pvt. Ltd.
|
India
|
Automatic Renewal
|
31 January 2023
|
04 September 2028
|
| View |
|
DR-XY47752
|
Ascorbic Acid
|
Marphen C
|
600mg (equivalent to 553.40mg Ascorbic Acid and 46.60mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Herbz Med Pharma Corporation
|
Philippines
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DRP-11335
|
dl-alpha Tocopheryl Acetate (Vitamin E)
|
Nova-E
|
400 IU
|
Soft Gelatin Capsule
|
Vitamin
|
Softgel Healthcare Private Limited
|
India
|
Initial
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-11337
|
Orlistat
|
Novastat 60
|
60 mg
|
Capsule
|
Anti-Obesity
|
Acme Generics LLP.
|
India
|
Initial
|
03 March 2022
|
03 March 2027
|
| View |
|
BR-1388
|
Meningococcal Group A, C, W-135 and Y Conjugate
Vaccine
|
Menquadfi
|
Formulation: Each dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide* .... 10 mcg Neisseria meningitidis group C polysaccharide* .... 10 mcg Neisseria meningitidis group Y polysaccharide* .... 10 mcg Neisseria meningitidis group W-135 polysaccharide* .... 10 mcg *Conjugated to Tetanus Toxoid carrier protein... 55 mcg** **Tetanus Toxoid quantity is approximate and dependent on the polysaccharide to protein ratio for the conjugates in each formulation
|
Solution for Injection (IM)
|
Vaccines
|
Sanofi Pasteur
|
United States of America
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
|
DRP-11336
|
Iron
|
Saphiron - 44
|
44 mg (equivalent to 220 mg Ferrous Sulfate
Heptahydrate)/5 mL
|
Syrup (Orange Flavor)
|
Mineral
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
03 March 2022
|
03 March 2027
|
| View |
|
DR-XY47771
|
Ascorbic Acid + Cholecalciferol + Calcium + Zinc
|
Immuno CDZ
|
495mg/10mg/55mg/3.75mg
|
Capsule
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
-
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-9612
|
Multivitamins + Iron
|
Ferrinova
|
Formulation Each Film-Coated Tablet contains: Ascorbic Acid (Vitamin C)-100 mg Pyridoxine (Vitamin B6)-10 mg Riboflavin (Vitamin B2)-3 mg Thiamine Mononitrate (Vitamin B1)-3 mg Cyanocobalamin (vitamin12-10mcg Folic Acid (Vitamin B9)-3 mg Iron
- 100 mg (equivalent to 314.30 mg Iron (III) Hydroxide Polymaltose Complex)
|
Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
Initial (OTC)
|
10 March 2022
|
25 March 2026
|
| View |
|
DRP-9812
|
Polyethylene Glycol 3350 (PEG) + Mineral Salts
|
Clearlax
|
Formulation Each sachet contains:
Macrogol 3350 (Polyethylene Glycol 3350)-13.125 mg Sodium Chloride-350.7 mg Sodium Hydrogen Carbonate-178.5 mg Potassium Chloride-46.6 mg
|
Powder For Oral Solution (Lemon flavor)
|
Osmotically Acting Laxative
|
SAGA Lifesciences Limited
|
India
|
Initial (OTC) [PCPR]
|
11 March 2022
|
14 June 2026
|
| View |
|
DRHR-2017
|
Povidone-Iodine
|
None
|
10 mg/mL (1% w/v)
|
Oral Solution (Gargle)
|
Antiseptic
|
Scheele Laboratories Phils., Inc.
|
Philippines
|
Initial [HR]
|
07 March 2022
|
25 June 2026
|
| View |
|
DRP-3850-02
|
Multivitamins + Amino Acids
|
Aminotrene
|
Formulation: Each capsule contains: Retinol (Vitamin A) Calciferol (Vitamin D) Tocopherol Acetate (Vitamin E) Thiamine Mononitrate (Vitamin B) Riboflavin (Vitamin B2) Nicotinamide (Vitamin B3)
Pyridoxine Hydrochloride (Vitamin B ) Folic Acid (Vitamin B,) Calcium Pantothenate Cyanocobalamin (Vitamin B12)
2,000 IU 200 IU
1 mg 5 mg 3 mg 20 mg 2.5 mg 200 mcg
5 mg 1 mcg
Ascorbic Acid (Vitamin C) 5-Oxyanthranilic Acid L-Leucine L-Isoleucine L-Lysine HCI L-Phenylalanine L-Threonine L-Valine L-Acetyltryptophan L-Methionine
20 mg 20 mcg 18.30 mg 5.9 mg 25 mg
5 mg 4.2 mg 6.7 mg
5 mg 18.4 mg
|
Capsule
|
Vitamins
|
Morishita-Seggs Pharmaceuticals, Inc.
|
Philippines
|
Renewal
|
27 June 2022
|
26 March 2027
|
| View |
|
DR-XY47778
|
Amlodipine (as besilate) + Valsartan
|
Exnin
|
10 mg/ 160 mg
|
Film Coated Tablet
|
Angiotensin II Receptor Blocker + Calcium Channel
Blocker
|
Myungmoon Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DRP-11421
|
Pantoprazole
|
Ulcepan
|
40mg (equivalent to 42.3mg Pantoprazole sodium)
|
Lyophilized Powder for Solution for Injection (I.V. Infusion)
|
Proton Pump Inhibitor
|
Gland Pharma Limited
|
India
|
Initial (Rx)
|
02 June 2022
|
10 March 2027
|
| View |
|
DR-XY47799
|
Lactulose
|
Lactowyn
|
10g/15mL
|
Oral Solution
|
Laxatives/ Cathartics
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 May 2022
|
10 March 2027
|
| View |
|
DR-XY 47806
|
Nepafenac
|
Ilevro
|
3 mg/mL (0.3 % w/v)
|
Sterile Ophthalmic Suspension
|
-
|
Alcon-Couvreur NV
|
Belgium
|
Monitored Release
|
16 May 2022
|
10 March 2027
|
| View |
|
DR-XY40106
|
Paracetamol
|
None
|
500mg
|
Tablet
|
-
|
North China Pharmaceutical Qin Huang Dao Co., Ltd.
|
China
|
-
|
08 March 2022
|
29 September 2026
|
| View |
|
DR-XY47790
|
Efavirenz
|
None
|
600 mg
|
tablet
|
Antiviral (Non-Nucleoside Reverse Transcriptase
Inhibitor)
|
Micro Labs Limited
|
India
|
Monitored Release
|
08 March 2022
|
08 March 2027
|
| View |
|
DRP-11400
|
Clotrimazole
|
Imazole 500-V
|
500 mg
|
Pessary
|
Antifungal
|
Bliss GVS Pharma Ltd.
|
India
|
Initial (Correction)
|
16 May 2022
|
08 March 2027
|
| View |
DR-XY47801_PI_01.pdf
|
DR-XY47801
|
Valporic Acid
|
Vallepsy
|
250 mg5/mL
|
Syrup
|
Anticonvulsant
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DR-XY 47798
|
Cefotaxime (As Sodium)
|
Anzoxim
|
1 g
|
Powder For Injection (I.M./I.V.)
|
Antibacterial
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
10 March 2022
|
10 March 2027
|