| View |
|
HMR-170
|
Pelargonium sidoides DC. Root
|
None
|
20mg
|
Softgel Capsule
|
Cough and Cold Relief
|
UNILAB, Inc.
|
Philippines
|
Initial
|
21 February 2022
|
21 February 2027
|
| View |
|
DR-XY47739
|
Doripenem (as monohydrate)
|
Dopinem
|
500mg
|
Powder for Infusion (IV)
|
Antibacterial (Carbapenem)
|
PT. Dexa Medica
|
Indonesia
|
Initial
|
18 February 2022
|
18 February 2027
|
| View |
|
DRP-11272
|
Warfarin Sodium
|
Neorof
|
2.5 mg
|
Tablet
|
Antithrombotic
|
Agio Pharmaceuticals Ltd.
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DR-XY47757
|
First Aid Kit
|
Mediplast
|
Contents:
Paracetamol (Biogesic) 500mg-4pc Tablet Chlorphenamine Maleate + Phenylpropanolamine Hydrochloride + Paracetamol (Decolgen Forte) 2mg/25mg/500mg Tablet-4pc Loperamide Hydrochloride 2mg Capsule-4pc Benzocaine + Boric Acid + Eucalyptus (Dermalin Burn) 10mg/50mg/15mg Ointment-1 tube Povidone lodine 10% Solution-15mL
Aromatic Spirit of Ammonia 3.4g/3.6mL per (Der100ml Solution-15mL Camphor + Menthol + Eucalyptus Oil (Rhea Cold Rub) 6g/4g/1.6g Ointment-1pc Babyflo Gentle Cotton Buds x 36's-1Pack Mediplast Acrinol 40mg/10g Plastic Strip-4pc Leukoplast Adhesive Tape-1pc Mediplast Gauze Pad (2in x 2in)-1pc
|
|
N/A
|
Philusa Corporation
|
Philippines
|
Initial
|
24 February 2022
|
24 February 2027
|
| View |
|
DR-XY47756
|
Complete Wound Management Kit
|
Mediplast
|
Contents:
Isopropyl Alcohol 70% Solution-250ml Hydrogen peroxide 10 Volumes Solution-120mL Povidone Iodine 10% Solution- 15mL Cleene Absorbent Cotton (Polybag) x 10g-I roll Mediplast Acrinol 40mg/10g Plastic Strip x 12's-1 box 3x3 Mediplast Gauze Pads- 2 pc 2x2 Mediplast Gauze Pads-2 pc 2x6 Mediplast Gauze Pads-2 pc Meditape Hospital Paper Tape 1.25cm x 9.1m-1 roll
|
NA
|
-
|
Philusa Corporation
|
Philippines
|
-
|
24 February 2022
|
24 February 2027
|
| View |
|
DR-XY47746
|
Naltrexone Hydrochloride
|
Nodict
|
50 mg
|
Film-Coated Tablet
|
Opioid Antagonist
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
27 June 2024
|
22 February 2027
|
| View |
DR-XY47755_PI_01.pdf
|
DR-XY47755
|
Doxofylline
|
Maxivent
|
200mg
|
Tablet
|
Drug for Obstructive Airway Diseases (Xanthine)
|
Ajanta Pharma Limited
|
India
|
Monitored Release (Correction)
|
26 July 2024
|
24 February 2027
|
| View |
|
DRP-11276
|
Multivitamins + Dextrose
|
Vitalex-500
|
25 g
Formulation: Each 500 mL contains: Dextrose (Glucose) Nicotinamide Ascorbic Acid (Vitamin C) Dexpanthenol
Thiamine hydrochloride (Vitamin B1) Riboflavin (as sodium phosphate) (Vitamin B2) Pyridoxine hydrochloride (Vitamin B )
625 mg 500 mg 250 mg 125 mg 25 mg 25 mg
|
Solution for Injection (I.V. Infusion)
|
Parenteral Nutrition
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11243
|
Alendronic Acid (as alendronate sodium)
|
None
|
70mg
|
Tablet
|
Bisphosphonate
|
Yooyoung Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
17 February 2022
|
17 February 2027
|
| View |
|
DRP-11273
|
Levocetirizine hydrochloride
|
Novazine
|
5 mg
|
Orally Disintegrating Tablet
|
Antihistamine (Piperazine Derivative)
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Monitored Release
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11313
|
Co-Amoxiclav
|
Seaclavin 1200
|
Formulation: Each vial contains: Amoxicillin (as sodium)... 1g Clavulanic acid (as Potassium Clavulanate) ... 200 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
24 February 2022
|
24 February 2027
|
| View |
|
DRP-11275
|
Amino Acids
|
Chiamin-A
|
50 mg/mL (5% w/v) Each mL contains: L-Methionine
2.15 mg
Each mL contains:
7,00 mg
L-Serine
L-Alanine
L-Arginine HCI (eq. to L-Argine)
6.00 mg
L-Valine
3.25 mg 3.10 mg
L-Histidine HCLH2O
1.50 mg
(eq. to L-Histidine)
L-Proline
5.60 ing
Glycine
5.50 mg
L-Leucine
L-Lysine HCI (eg. to L-Lysine)
3.70 mg 3.30 mg
L-Phenylalanine L-Isoluccine L-Threonine
2.55 mg
L-Tryptophan
1.00 mg
500 mcg
2.50 mg
200 mcg
2.20 mg
Taurine
L-Tyrosine
|
Solution for Injection for I. V.
Infusion
|
Parenteral Nutrition
|
Siu Guan Chem. Ind. Co., Ltd.
|
Taiwan
|
Initial (Correction)
|
06 June 2024
|
22 February 2027
|
| View |
|
DRP-11282
|
Acetylcysteine
|
None
|
600mg
|
Granules For Oral Solution
|
Mucolytic
|
Lifesquare Laboratories, Inc.
|
Philippines
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DRP-11281
|
Acetylcysteine
|
None
|
200mg
|
Granules For Oral Solution
|
Mucolytic
|
Lifesquare Laboratories, Inc.
|
Philippines
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DRP-11283
|
Flumazenil
|
Zenil
|
500mcg/5mL
|
Solution For IV Injection
|
Benzodiazepene antagonist
|
Myungmoon Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DRP-11259
|
Atracurium Besilate
|
None
|
10 mg/mL (25 mg/2.5 mL and 50 mg/5 mL)
|
Solution for Injection for I.V. Infusion
|
Peripherally Acting Muscle Relaxant
|
Siegfried Hameln GmbH
|
Germany
|
Initial
|
18 February 2022
|
18 February 2027
|
| View |
|
DRP-11244
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Zerone-Sul
|
1g/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin/Beta-lactamase Inhibitor)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Monitored Release
|
18 February 2022
|
18 February 2027
|
| View |
|
DR-XY47741
|
Voriconazole
|
Trilam
|
200 mg
|
Powder For Injection (I.V.)
|
Antifungal
|
Mylan Laboratories Limited (Hosur Sterile Facility)
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11262
|
Topotecan (as hydrochloride)
|
Topoccord 4
|
1 mg/mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11289
|
Metronidazole (As Benzoate)
|
None
|
125 mg / 5 mL
|
Oral Suspension
|
Antiprotozoal/Antibacterial (Nitroimidazole derivative)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
23 February 2022
|
23 February 2027
|