EUCTD DOSSIERS

Sr. No. Generic Name Strength Dosage Form Therapeutic Category

1

Clotrimazole Vaginal tablet

500 mg

Suppository

Antibiotic

2

Clonidine

25 mcg

Tablet

Antihypertensive

3

Metformin SR

500/750/1000 mg

Sustained Release Tablet

Antidiabetic

4

Ibuprofen

400 mg

Softgels

NSAID

5

Hyoscine Butylbromide

10 mg

Tablets

antispasmodic

6

Sodium Picosulfate Magnesium Oxide Citric acid

10mg+3.5g+12g

Sachets

Bowel clearance before surgery

7

Acetaminophen, Dextromethorphan HBR & Phenylephrine HCL

650mg+20mg+10mg

Powder for Sachet

Antitussive, antipyretic, Nasal Decongestant

8

Acetaminophen Diphenhydramine HCL & Phenylephrine HCL

650mg+25mg+10mg

Powder for Sachet

Antitussive, antipyretic, Nasal Decongestant

9

Bilastine

20 mg

Tablets

Antihistamine

10

Rivaroxaban

10/15/20 mg

Tablets

Anticoagulant

11

Diclofenac Potassium

25 mg

Effervescent tablets

Analgesic

12

Fosfomycin

3gm

Sachets

Antibiotic (UTI)

13

Loratadine

5mg

Chewable l

Tablets

Antihistamine

14

Pregabalin ER

82.5/165,330 mg

Tablets

Antiepileptic

15

Sevelamer

0.8/2.4 gm

Powder

Treatment of Hyperphosphatemia

16

Metformin + Sitagliptin ER

50/500, 50/1000, 100/1000 mg

Tablets

Type 2 Diabetes Mellitus

17

Ibuprofen Acetaminophen

125mg + 250 mg

Tablets

Anti-inflammatory

18

Metformin + Sitagliptin IR

50/500, 50/850, 50/1000 mg

Tablets

Type 2 Diabetes Mellitus

19

Esomeprazole DR MUPPS

20/40 mg

Tablets

Proto pump Inhibitor

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