| View |
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DR-XY46750
|
Metronidazole + Miconazole nitrate
|
Metromic
|
500 mg + 100 mg
|
Vaginal Suppositories
|
Antiprotozoal/Anti-infective
|
Kusum Healthcare Private Limited
|
India
|
Renewal
|
12 June 2024
|
18 October 2029
|
| View |
|
DR-XY46751
|
Metronidazole + Miconazole nitrate
|
Metromic Forte
|
750 mg + 200 mg
|
Vaginal Suppositories
|
Antiprotozoal/Anti-infective
|
Kusum Healthcare Private Limited
|
India
|
Renewal
|
27 May 2024
|
18 October 2029
|
| View |
|
DR-XY46752
|
Cefuroxime
|
Sanfurox-750
|
750mg
|
Dry Powder For Injection (IM/IV)
|
-
|
Inject Care Perenterals Pvt. Ltd.
|
India
|
-
|
22 October 2019
|
22 October 2024
|
| View |
|
DR-XY46753
|
Guaifenesin + Dextromethorphan Hydrobromide + Phenylpropanolamine Hydrochloride
|
Dynatussin
|
50 mg/ 10 mg/ 10 mg
|
Syrup
|
-
|
Hizon Laboratories, Inc.
|
Philippines
|
-
|
22 October 2019
|
22 October 2024
|
| View |
|
DR-XY46754
|
Ascorbic Acid (as Sodium Ascorbate)
|
Truceevit
|
500 mg (equivalent 568.18 mg
|
Sodium Ascorbate)
|
Vitamins
|
Saga Lifesciences Limited
|
India
|
Renewal
|
05 August 2022
|
22 October 2027
|
| View |
|
DR-XY46755
|
Fenofibrate + Atorvastatin ( as calcium )
|
Fibrovas
|
160mg/ 10mg
|
Film-Coated Tablet
|
Lipid Modifying Agent + HMG CoA Reductase Inhibitor
|
Micro Labs Limited
|
India
|
Renewal
|
17 May 2024
|
24 October 2029
|
| View |
DR-XY46756_PIL_01.pdf
|
DR-XY46756
|
Dextromethophan Hydrobromide
|
Bronchilax
|
10mg
|
Tablet
|
Antitussives
|
San Marino Laboratories Corporation
|
Philippines
|
Automatic Renewal
|
20 September 2022
|
28 October 2027
|
| View |
|
DR-XY46757
|
7% Amino Acids
|
Nutrimax
|
Formulation: Each 100 mL contains: L-Glutamic Acid-900mg L-Proline-810mg L-Serine-750mg L-Phenylalanine-550mg L-Leucine-530mg L-Lysine HCI-490mg L-Valine-430mg L-Aspartic Acid-410mg L-Isoleucine-390mg
L-Arginine HCI-330mg L-Alanine-300mg L-Threonine-300mg L-Histidine HCI-240mg L-Glycine-210mg L-Methionine-190mg L-Tryptophan-100mg L-Tyrosine-50mg L-Cysteine HCI-14.50mg
|
Solution For IV Infusion
|
Parenteral Nutrition
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial (Variation)
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY46758
|
5% Amino Acids
|
Nutrimax
|
Each 100 mL contains: L-Glycine-760.00mg L-Phenylalanine-534.00mg L-Arginine HCI-500.00mg L-Leucine-490.00mg L-Lysine HCI-430mg L-Valine-360mg L-Isoleucine-352.00mg L-Aspartic acid-250.00mg L-Histidine HCI-250.00mg
L-Threonine-250.00mg L-Methionine-225.00mg L-Alanine-200.00mg L-Proline-100.00mg L-Serine-100.00mg L-Tryptophan-90.300mg L-Glutamic acid-75.00mg L-Tyrosine-25.00mg L-Cystine HCI-10.00mg
|
Solution For IV Infusion
|
-
|
Cisen Pharmaceutical Co., Ltd
|
China
|
Initial (Compliance) (Revalidation)
|
29 September 2021
|
25 October 2024
|
| View |
|
DR-XY46759
|
Olapatadine (as hydrochloride)
|
Rapidon
|
2mg/mL ( 0.2 w/v)
|
Opthalmic Solution (eye Drops)
|
-
|
Micro Labs Limited
|
India
|
-
|
31 October 2019
|
31 October 2024
|
| View |
|
DR-XY46760
|
Letrozole
|
Femaplex
|
2.5mg
|
Film-Coated Tablet
|
-
|
Genepharm S.A.
|
Greece
|
-
|
18 December 2019
|
18 December 2024
|
| View |
|
DR-XY46761
|
Valsartan + Hydrochlorothiazide
|
Torval H 320 / 25
|
320 mg / 25 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharma Philippines, Inc.
|
India
|
-
|
11 November 2019
|
11 November 2024
|
| View |
|
DR-XY46762
|
Valsartan + Hydrochlorothiazide
|
Torval H 320/12.5
|
320mg / 12.5mg
|
Film-Coated Tablet
|
-
|
Torrent Pharma Philippines, Inc.
|
India
|
-
|
11 November 2019
|
11 November 2024
|
| View |
|
DR-XY46765
|
Valganciclovir (as hydrochloride)
|
Valvir-450
|
450mg
|
Film Coated Tablet
|
Direct Acting Antivirals (Nucleosides and Nucleotides excl. Reverse Transcriptase Inhibitors)
|
Hetero Labs Limited
|
India
|
Renewal
|
15 June 2024
|
19 November 2029
|
| View |
|
DR-XY46766
|
Acetylcysteine
|
Pulmonac
|
600 mg
|
Granules for Oral Solution
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
22 November 2019
|
22 November 2024
|
| View |
|
DR-XY46767
|
Acetylcysteine
|
Pulmonac
|
200mg
|
Granules for Oral Solution
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
22 November 2019
|
22 November 2024
|
| View |
|
DR-XY46768
|
Acetylcysteine
|
Pulmonac
|
100mg
|
Granules for Oral Solution
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
22 November 2019
|
22 November 2024
|
| View |
DR-XY46769_PI_01.pdf
|
DR-XY46769
|
Trimetazidine Dihydrochloride
|
Vastarel Od
|
80 mg
|
Prolonged-Release Hard Capsule
|
-
|
Egis Pharmaceuticals PLC Site 3
|
Hungary
|
-
|
22 November 2019
|
22 November 2024
|
| View |
|
DR-XY46770
|
Cefuroxime
|
Ducef
|
750mg
|
Dry Powder for Injection (IM/IV)
|
Anti-infectives (Second-generation cephalosporins)
|
Theon Pharmaceuticals Limited
|
India
|
Initial (Correction)(Reconstruction)
|
03 November 2022
|
27 November 2024
|
| View |
|
DR-XY46771
|
Cefuroxime Sodium
|
Ducef
|
1.5g
|
Dry Powder for Injection (IM/IV)
|
Anti-infectives (Second-generation cephalosporins)
|
Theon Pharmaceuticals Limited
|
India
|
Initial (Correction)(Reconstruction)
|
03 November 2022
|
27 November 2024
|