Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
40. Amoxycillin 250mg/125mg 30-01-08
+ Cloxacillin 250mg/125mg
+ Lactobacillus Bacillus 1.7 Billion spores
For RTI, SRS. of tissue infection, bone & joint
infection, ENT infection in adults prone to
antibiotic diarrhoea
41. Amoxicillin 250mg 30-01-08
+ Lactobacillus 1.7 Billion spores
For RTI, SRS. of tissue infection, bone & joint
infection, ENT infection in adults prone to
antibiotic diarrhoea
45. Amoxicillin 250mg 30-01-08
+Cloxacillin 250mg
+ Lactobacillus 2 Billion sores capsules
For the treatment of lower RTI, skin & soft tissue
bone & joint infections, ENT infections in adult
patients prone to antibotic associated diarrhoea
68. Amoxucillin 125mg/250mg/500mg 31-01-08
+ Lactobacills
For the treatment of respiratory tract infection,
skin and soft tissue infections & antobiotics
associated diarrhoea
248. Amoxycillin 25-11-08
+ Clavulanic acid (1gm + 62.5mg)
FC tablets
For the treatment and management of patients
with community acquired pneumonia or acute
bacterial sinusitis due to beta lactamase
producing pathogens
U.S.FDA APPROVED DRUGS DURING 2006
62. Amoxycillin 1000mg 08-06-2006
+Clavulanate Potassium 62.5mg ER tablet Anti-biotic 112. Amoxycillin 250mg 28-08-2006
+ Dicloxacillin 250mg cap
Anti-biotic
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Each 1ml of the constituted suspension contains- 14-10-2014
Amoxycillin Trihydrate IP eq. to Amoxycillin 80mg+
Potassium Clavulanate IP eq to Clavulanic acid 11.4mg
Addl.stgth
For the treatment of infections due to susceptible isolates
of the designated bacteria in the conditions such as lower
Respiratory Tract Infections , Acute Bacterial Otitis Media,
Skin and skin structure infections, Urinary Tract infections
in children more than 20kg body weight
2.Each 5ml of reconstituted suspension contains: 18-09-2014
Amoxicillin Trihydrate IP eq to Amoxicillin 200mg/400mg+
Potassium Clavulanate IP eq.to clavulanic acid 28.5mg/57mg
Addl.Stgth
For the treatment of bacterial infection such as Sinusitis Otitis
Media. Tonsilitis acute and chronic bronchtis, skin and soft
tissue infections and post operative pain
3. Each 5ml reconstituted syrup contains: 07-08-1990
Amoxycillin as trihydrate 125mg +
Clavulanic Acid 31.25mg as Potassium salt suspension
4.Each combipack contains: 14-10-2014
A- Each 5ml of constututed suspension contains:
i. Amoxicillin trihydrate IP eq.to Amoxicillin 200mg +
Potassium Clavulanate IP eq. to Clavulanic acid 28.5mg
ii. Amoxicillin rihydrate eq.to amoxicillin 400mg +
Potassium Clavulanate IP eq.to Clavulanic acid 57mg
B- One vial of purified water IP Each Vial contains
Purified water IP 30ml
Addl.Pack
For the treatment of bacterial infection such as Sinusitis
Otitis Media, Tonsilitis, Acute and chronic bronchitis ,
Skin and soft tissue infections and post operative pain
5. Potassium Calvulanic eq. to 05-04-1980
Clavulanic Acid 125mg +
Amoxycillin trihydrate
eq to Amoxycillin 250mg tablet
For the treatment of bacterial infections such as sinusitis.
ottitis media, tonsilitis, acute and chronic bronchitis,skin
post operative pain
6.Sterile Amoxycillin eq.to 21-06-1996
Amoxycillin 500gm/1gm +
Sterile Sulbatum eq.to
Sulbactum 250mg/500mg each vial inj
Antibiotic
Lower respiratory infections
Skin and soft tissue infection
Urinary tract infections
Post operative infection
Osteomylitis
Penicillins include
Natural-
Penicillin G, Penicillin V Penicillase -Resistent- Cloxacillin, Docloxacillin, Methicillin, Nafacillin, Oxacillin
Aminopenicillins-
Amoxycillin, Amoxycillin/Potassium Clavulanate, Ampicillin, Ampicillin/Sulbactum, Becampicillin
Extended spectrum-
Carbenicilin, Mezlocillin, Piperacillin.Tazobactam sodium, Ticarcillin, Ticarcillin/Potassium clavulanate
Refer Penicillin V Potassium
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1. Amoxicillin 250mg + lacto-bacillus 1.7 billion 31-02-2008
spores
For RTI. SRS of soft tissue infection, bone and joint infection,
ENT infection, in adults prone to antibitic associated diarrhea
2.Amoxicilin 250mg/125mg + cloxaxillin 250mg/125mg + 30-01-2008
lactic acid bacillus 1.7 billion spores
For RTI. SRS of soft tissue infection, bone and joint infection,
ENT infection, in adults prone to antibitic associated diarrhea
3.Amoxicillin + Clavulanic acid 1gm + 62.6mg FC tabs 25-11-2008
For the treatment and mangement of patients with community
acquired pneumonia or acute bacterial sinusitis due to
beta lactamase producing pathogens
4.Amoxicillin 1000mg + Clavulanate potassium 62.5mg 08-06-2006
ER tablet
Anti-biotic
5. Amoxicillin 125mg/250mg/500mg + 31-01-2008
lactobacillus 1.66 billion spores capsules
For the treatment of respiratory tract infection, skin and soft
tissue infections and antibiotic associated diarrhea
in adult patients
6. Amoxicillin 250mg + Cloxacillin 250mg + Lactobacillus 30-01-2008
2 Billion spores capsules
For the treatment of lower RTI, skin and soft tissue bone and
joint infection, and ENT infections in adult patients prone to
antibiotic associated diarrhea
7.Amoxicilin 250mg + Dicloxacillin 250mg capsules 28-08-2006
Antibiotic
8. Amoxicillin oral suspension 200/400mg /5ml 09-08-2010
In the treatment of infections due to susceptible strains of the
designated micro-oragnanism in the condition of ENT infection,
skin and skin structure infection, lower respiratory tract infection,
Genito - urinary tract infection, Gonorrhea, acute uncomplicated
(anogenital and urethreal ) infections
