View |
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DR-XY45722
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Pemetrexed (As Disodium Hemipentahydrate)
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Bagoxed
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500 mg
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Lyophilized Powder For Infusion (Iv)
|
-
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Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial (from Monitored Release)
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02 February 2023
|
06 March 2027
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View |
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DR-XY45728
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Triamcinolone acetonide
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Trilac
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10mg/ mL
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Suspension for Injection (Intra-articular/Intradermal)
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Corticosteroid
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PT. Novell Pharmaceutical Laboratories
|
Indonesia
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Automatic Renewal
|
14 January 2022
|
11 January 2027
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View |
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DR-XY45730
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Meropenem (as Trihydrate)
|
Merogram 1000
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1g
|
Powder for IV Injection
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Antibacterial
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Auronext Pharma Pvt. Ltd.
|
India
|
Automatic Renewal
|
02 February 2022
|
09 January 2027
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View |
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DR-XY45733
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Empagliflozin + Linagliptin
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Glyxambi
|
25mg/5mg
|
Film-coated Tablet
|
-
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Boehringer Ingelheim Pharma GmbH & Co. KG
|
Germany
|
-
|
11 April 2022
|
09 January 2027
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View |
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DR-XY45734
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Empagliflozin + Linagliptin
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Glyxambi
|
10mg/5mg
|
Film-coated Tablet
|
-
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Boehringer Ingelheim Pharma GmbH & Co. KG
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Germany
|
-
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11 April 2022
|
09 January 2027
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View |
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DR-XY45735
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Mefenamic Acid
|
Fenaway
|
500mg
|
Film-Coated Tablet
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Non-Steroidal Anti-Inflammatory Drug (NSAID)
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Nishchay Lifesciences, Inc.
|
India
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Automatic Renewal
|
17 January 2022
|
12 January 2027
|
View |
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DR-XY45736
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Adapalene + Clindamycin (as phosphate)
|
Akneclin Plus
|
1 mg/10 mg (0.1% / 1% w/w) per gram
|
Topical Gel
|
Anti-acne
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Curetech Skincare
|
India
|
Renewal
|
14 February 2022
|
13 January 2027
|
View |
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DR-XY45737
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Pantoprazole (as sodium sesquihydrate)
|
Pantopraz IV
|
40mg
|
Powder for Injection (IV)
|
Proton Pump Inhibitors
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Dongkwang Pharm. Co., Ltd.
|
Korea
|
Automatic Renewal
|
30 December 2021
|
13 January 2027
|
View |
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DR-XY45739
|
Metformin hydrochloride
|
None
|
500mg
|
Film-Coated Tablet
|
Oral Hypoglycemic
|
Hizon Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
30 December 2021
|
12 January 2027
|
View |
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DR-XY45741
|
Adapalene + Benzoyl Peroxide
|
Epiduo
|
1 mg/25 mg per gram (0.1%/2.5% w/w)
|
Topical Gel
|
Anti-acne
|
Laboratories Galderma
|
France
|
Initial (Variation)
|
05 July 2022
|
17 January 2027
|
View |
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DR-XY45742
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Tenofovir Disoproxil Fumarate
|
Tenofo-B
|
300mg
|
Film-Coated Tablet
|
-
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Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial (from Monitored Release status)
|
09 June 2023
|
30 January 2027
|
View |
DR-XY45743_PI_01.pdf
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DR-XY45743
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Teneligliptin (as Hydrobromide Hydrate)
|
Glipten
|
20 mg
|
Film-Coated Tablet
|
-
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Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release status) (Correction)
|
15 September 2023
|
12 January 2027
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View |
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DR-XY45744
|
Fluconazole
|
Medoflucon
|
150mg
|
Capsule
|
ANTIFUNGAL
|
Medochemie Ltd.
|
Cyprus
|
Automatic Renewal
|
28 December 2021
|
16 January 2027
|
View |
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DR-XY45746
|
Ceftriaxone (as sodium)
|
FRIAXXSO
|
1g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Pvt. Ltd.
|
India
|
Automatic Renewal
|
02 February 2022
|
17 January 2027
|
View |
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DR-XY45747
|
Ascorbic Acid + Zinc (as sulfate monohydrate)
|
Ceelin Plus
|
40 mg/5 mg per mL
|
Syrup (Oral Drops)
|
Vitamin + Mineral
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
18 February 2022
|
31 January 2027
|
View |
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DR-XY45748
|
Latanoprost + Timolol (as maleate)
|
Xalanol
|
50 mcg/5 mg per mL (0.005% / 0.5%)
|
Ophthalmic Solution (Eye Drops)
|
Anti-Glaucoma
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
Renewal
|
21 September 2021
|
16 January 2027
|
View |
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DR-XY45749
|
Triptorelin (as Acetate)
|
DECAPEPTYL
|
100mcg / mL
|
Solution for Injection (SC)
|
Gonadotropin Releasing Hormone Analogue
|
Ferring GmbH
|
Germany
|
Renewal
|
21 January 2022
|
08 February 2027
|
View |
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DR-XY45756
|
Fluconazole
|
Flucopharm
|
2 mg/mL (100 mg/50 mL and 200 mg/100 mL)
|
Solution for I.V. Infusion
|
Antifungal
|
Yuria-Pharma Ltd.
|
Ukraine
|
Automatic Renewal
|
21 September 2021
|
24 January 2027
|
View |
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DR-XY45757
|
7% Amino Acids
|
Nutrimax
|
Formulation: Each 100 mL contains L-Glutamic Acid-900.00mg L-Proline-810.00mg L-Serine-750.00mg L-Phenylalanine-550.00mg L-Leucine-530.00mg L-Lysine HCI-490.00mg L-Valine-430.00mg L-Aspartic Acid-410.00mg L-Isoleucine-390.00mg
L-Arginine HCI-330.00mg L-Alanine-300.00mg L-Threonine-300.00mg L-Histidine HCI-240.00mg L-Glycine-210.00mg L-Methionine-190.00mg L-Tryptophan-100.00mg L-Tyrosine-50.00mg L-Cystine HCI-14.50mg
|
Solution For I.V. Infusion
|
Parenteral Nutrition
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Automatic Renewal (Compliance)
|
23 June 2021
|
25 October 2024
|
View |
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DR-XY45759
|
Tramadol Hydrochloride + Paracetamol
|
Duocetz
|
37.5 mg / 325 mg
|
Film-Coated Tablet
|
-
|
Mega Lifesciences Public Company Limited
|
Thailand
|
Automatic Renewal
|
24 June 2021
|
26 January 2027
|