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 Fixed Dose Combinations ( FDC )


Fixed Dose Combination (FDC) is a combination of two or more pharmaceutically active ingredients to make a single dosage which is prescribed in a fixed dose. FDC improves the efficacy of a medicy of a medicine thus reducing the number of pills taken by the patient.

 

When two drugs combine, they become a new drug which require approval and license for manufacture. The license is approved by the State Drug Controller, and approval is provided by the Drug Controller General of India (DCGI).

Presently, 294 FDCs are pending for approval by the DCGI after the licenses were issued from State Drug Controller. Out of the 294 FDCs, 78 FDCs are liable to get approval by the DCGI under certain conditions. The list of those 78 FDCs is as given below:

 

 

S. No.

Name of FDC

Category

Remarks

1.

Ibuprofen + Colchicine

Orthopedics

 

2.

Aloe extract + Allantocin + Alfa tocoferal acetate + D-panthemol + Vit A

Dermatologicals

Should be Topical

3.

Allantoin + Vit-E + Cammelina Sinensis

Dermatologicals

Should be Topical

4.

Aloe extract + Vit-E + Dimethicone + Glycerine

Dermatologicals

Should be Topical

5.

Aloe vera + jojoba oil + Vit-E

Dermatologicals

Should be Topical

6.

Aloe vera + Orange oil

Dermatologicals

Should be Topical

7.

Aloe vera + Vit-E acetate

Dermatologicals

Should be Topical

8.

Aloe + tocopherol

Dermatologicals

Should be Topical

9.

Aloe vera + Glycerine + PFG 100 stearate + Vit-E

Dermatologicals

Should be Topical

10.

Aloe vera + Jojoba Oil + Wheat germ oil + Tea tree oil

Dermatologicals

Should be Topical

11.

Aloe vera + Vit-E + Herbal

Dermatologicals

Should be Topical

12.

Chlorzoxazone + Nimesulide

Orthopaedics

 

13.

Chlorzoxazone + Paracetamol

Orthopaedics

 

14.

Diclofenac + Tizanidine

Orthopaedics

 

15.

Drotaverine hydrochloride + Mefenamic acid

Gastrointestinal

 

16.

Drotaverine + Mefenamic acid

Gastrointestinal

 

17.

Drotaverine + Nimesulide

Gastrointestinal

 

18.

Ibuprofen + Dextropropoxyphene

Orthopaedics

 

19.

Ibuprofen + Tizanidine

Orthopaedics

 

20.

Mecobalaminalphalipoic Acid + Folic acid + Vit B6 + Choline

Nutritionals

Doses of Vitamins should be as per Schedule V

21.

Mecobalamine + Alpha lipoic acid

Nutritionals

Doses of Vitamins should be as per Schedule V

22.

Mecobalamine + Alpha lipoic acid + Folic acid

Nutritionals

Doses of Vitamins should be as per Schedule V

23.

Mecobalamine + Alpha lipoic acid + Vit B1 + Folic acid.

Nutritionals

Doses of Vitamins should be as per Schedule V

24.

Mecobalamine + Biotin

Nutritionals

Doses of Vitamins should be as per Schedule V

25.

Mecobalamine + Calcium panothenate

Nutritionals

Doses of Vitamins should be as per Schedule V

26.

Mecobalamine + Carotinoid + Alpha lipoic acid + Chromim + Vit B1 + Vit B Complex

Nutritionals

Doses of Vitamins should be as per Schedule V

27.

Mecobalamine + Folic acid

Nutritionals

Doses of Vitamins should be as per Schedule V

28.

Mecobalamine + Methenamine mandelate

Nutritionals

Doses of Vitamins should be as per Schedule V

29.

Mecobalamine + Vit-A + Vit-E + Vit-C + Vit-B1 + Vit-B6 + Vit-D3 + Selenium

Nutritionals

Doses of Vitamins should be as per Schedule V

30.

Mecobalamine +Vitamins + Minerals

Nutritionals

Doses of Vitamins should be as per Schedule V

31.

Mecobalamine + Vit-B1 + Vit-B2 + Vit-B6 + Folic acid

Nutritionals

Doses of Vitamins should be as per Schedule V

32.

Mecobalamine + Vit-B1 + Vit-B6 + Folic acid + Alpha lipoic

Nutritionals

Doses of Vitamins should be as per Schedule V

33.

Mecobalamine + Vit-B1 + Vit-B6 + Nicotinamide + D-Panthenol

Nutritionals

Doses of Vitamins should be as per Schedule V

34.

Mecobalamine + Vit B6 + Folic acid

Nutritionals

Doses of Vitamins should be as per Schedule V

35.

Acetylcysteine + Selenomethionone + choline Bitartrate + Pyridoxine + Folic Acid+Vitamin E + Cyanocobalmin + Chromium Nicotinate + Manganese Sulfate + Zinc Sulfate

Nutritionals

Doses of Vitamins should be as per Schedule V

36.

Acriflavine + Gentain violet + Brilliant green

Dermatologicals

Should be topical

37.

Alendronate sodium + Calcium carbonate + Vit-D3

Orthopaedics

 

38.

Allantoin + Triclosan + Vit-E + Zinc Oxide

Dermatologicals

Should be topical

39.

Drotaverine + Paracetamol

GI

 

40.

Ibuprofen + Paracetamol + caffeine

Cough & Cold

 

41.

Ibuprofen + Pseudoephedrine + Chlorpheniramine

Cough & Cold

 

42.

Metoclopramide hydrochloride + Paracetamol

GI

 

43.

Acetyl salicylic acid + Ethoheptazine

Analgesics

 

44.

Norfloxacin + Ornidazole

GI

 

45.

Ofloxacin + Tinidazole

GI

 

46.

Aceclofenac + Tramadol

Orthopaedics

 

47.

5-bromosalicyl-4-chloranilide + salicylic acid

Dermatologicals

Should be topical

48.

Ofloxacin + Prednisolone

Opthalmic

Should be opthalmic solution

49.

Lansoprazole + Amoxycillin + Clarithromycin

GI

Should be combipack

50.

Lansoprazole + Amoxycillin + Tinidazole

GI

Should be combipack

51.

Lansoprazole + Tinidazole + Clarithromycin

GI

Should be combipack

52.

Ornidazole + Flucanazole + Azithromycin

Antimicrobial

Should be combipack

53.

Clinamycin + Clotrimazole + Metronidazole

Dematologicals

Should be topical

54.

Mupirocin + Metronidazole

Dematologicals

Should be topical

55.

Benfotimine + Pyridoxine + Mecobalamine +

Inositol + Alphalipoic acid

Nutritionals Doses of Vitamins should be as per schedule V

56.

Amoxycillin + Clavulanic acid + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

57.

Amoxycillin + Clavulanic acid + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

58.

Amoxycillin + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

59.

Amoxycillin + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

60.

Amoxycillin + Lactobacillus acidophilus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

61.

Amoxycillin + Lactobacillus acidophilus + Clavulanic acid

Antimicrobial

Dose of lactobacillus should be 5 billion per day

62.

Ampicillin + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

63.

Cefadroxyl + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

64.

Cefdinir + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

65.

Cefixime + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

66.

Cefixime + Lactobacillus acidophilus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

67.

Cefixime + Lactobacillus acvidophilus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

68.

Cefpodoximeprozetil + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

69.

Cefpodoxime + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

70.

Cefpodoxime + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

71.

Cefprozil + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

72.

Doxycycline + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

73.

Lincomycin + Lactobacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

74.

AmoxicillinCloxacillin + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

75.

Amoxicillin + Cloxacillin + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

76.

Amoxicillin + Cloxacillin + Lacto acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

77.

Ampicillin + Cloxacillin + Lactic acid bacillus

Antimicrobial

Dose of lactobacillus should be 5 billion per day

78.

Cefixime + Lactobacillus + Clavulanic acid

Antimicrobial

Dose of lactobacillus should be 5 billion per day


 





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