| View |
|
DRP-11083
|
Loperamide + Simeticone
|
Diatime
|
2 mg/125 mg Tablet
|
Tablet
|
Antimotility / Antiflatulent
|
Indeus Life Sciences Pvt. Ltd.
|
India
|
Initial (OTC)(Correction)
|
12 August 2022
|
03 February 2027
|
| View |
|
DRP-10137-01
|
Losartan Potassium + Hydrochlorothiazide
|
Genbloc
|
50mg/12.5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker/ Diuretic
|
ACME Formulation Pvt. Ltd.
|
India
|
CLIDP
|
04 February 2022
|
29 July 2026
|
| View |
|
DRP-8375-05
|
Bupivacaine Hydrochloride In 8 % Dextrose
|
Hevapine
|
5 mg/ mL (0.5 % w/v)
|
Solution For Intrathecal Injection
|
-
|
Farbe Firma
|
India
|
-
|
11 February 2022
|
23 April 2025
|
| View |
DRP-11108_PIL_01.pdf
|
DRP-11108
|
Butamirate Citrate
|
Welltrate
|
50 mg
|
Film-Coated Sustained-Release Tablet
|
Antitussive
|
Orion Pharma Ltd.
|
Bangladesh
|
Initial
|
03 February 2022
|
03 February 2027
|
| View |
|
DRHR-2124
|
Ethyl Alcohol
|
Doctor J
|
0.7
|
Solution (Unscented)
|
Antiseptic/Disinfectant
|
Kohl Industries Corporation
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DR-XY47717
|
Ascorbic Acid + Zinc + Colecalciferol (Vitamin D3)
|
Immunforte
|
500mg (equivalent to 562.43mg Sodium Ascorbate /
| 10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate /
1000 IU
|
Film-Coated Tablet
|
Vitamins / Mineral
|
UNILAB, Inc.
|
Philippines
|
Initial (OTC) correction
|
06 June 2022
|
09 February 2027
|
| View |
|
DRP-10199-01
|
Trimetazidine Hydrochloride
|
Trimestat
|
35mg
|
Modified-Release Tablet
|
Anti-angina
|
Zim Laboratories Limited
|
India
|
CLIDP
|
04 February 2022
|
04 August 2026
|
| View |
|
DRP-1973-05
|
Doxycycline (As Hyclate)
|
Doxyclene
|
100 mg
|
Capsule
|
Antibacterial (Tetracycline)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
01 March 2024
|
02 February 2029
|
| View |
|
DRP-10275-04
|
Febuxostat
|
Febuxden 40
|
40 mg
|
Film-Coated Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
-
|
11 February 2022
|
06 September 2026
|
| View |
|
DRP-10276-02
|
Febuxostat
|
Febuxden 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
-
|
11 February 2022
|
06 September 2026
|
| View |
|
DRP-1918-04
|
Phenylpropanolamine Hydrochloride + Brompheniramine Maleate
|
SinuCare
|
12.5 mg / 4 mg per 5 mL
|
Syrup
|
Decongestant / Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
23 May 2024
|
21 May 2029
|
| View |
|
DRP-293-03
|
Co-Amoxiclav
|
Clavexin
|
125 mg/31.25 mg per 5 mL
|
Powder For Suspension
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
25 April 2022
|
12 September 2026
|
| View |
|
HMR-168
|
Pelargonium sidoides DC.
|
None
|
12.5mg/ 5mL
|
Syrup
|
Cough & Cold Relief
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
HMR-169
|
Pelargonium sidoides DC
|
None
|
20mg/ 5mL
|
Syrup
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
09 February 2022
|
09 February 2027
|
| View |
|
DR-XY47723
|
Nebivolol (as hydrochloride) + Amlodipine (as besilate)
|
Nebilong -AM
|
5mg/ 5mg
|
Tablet
|
Beta Blocker-Calcium Channel Blocker Combination
|
Micro Labs Limited
|
India
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
DR-XY47720_PI_01.pdf
|
DR-XY47720
|
Zinc (as gluconate)
|
None
|
1mg/ mL
|
Concentrate for Solution for I.V. Infusion
|
Mineral Supplement
|
Laboratoire Aguettant
|
France
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DRP-11183
|
Rosuvastatin (as calcium)
|
Rosuxl 20
|
20mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
XL Laboratories Pvt. Ltd.
|
India
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DRP-11137
|
Paracetamol + Caffeine
|
Capasaph
|
500mg/ 50mg
|
Tablet
|
Analgesic/ Antipyretic
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Re-App)
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11093
|
Co-Amoxiclav
|
Cledomox
|
312.5mg/5mL
|
Powder For Oral Suspension
|
Antibacterial (Penicillin/Beta Lactamase Inhibitor)
|
Medopharm Private Limited
|
India
|
Initial
|
31 January 2022
|
31 January 2027
|
| View |
|
DRP-11106
|
Co-Amoxiclav
|
Augmeed 312.5
|
Formulation: Each 5 mL of reconstituted suspension contains:
Amoxicillin (as trihydrate)-250 mg Clavulanic Acid (as Potassium Clavulanate) -62.5 mg
|
Powder For Oral Suspension
|
Antibacterial (Penicillin/Beta Lactamase Inhibitor)
|
Medopharm Private Limited
|
India
|
Initial
|
03 February 2022
|
03 February 2027
|