Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
95. Ambroxol HCL 15mg 26-03-08
+ Guphenesin 50mg
+ Terbutalin sulphate 1.25mg
+ Menthol 2.5mg per 5ml of syrup
For symptomatic relief of bronchospasm in bronchial
asthma and chronic bronchitis
96. Ambroxol HCL 30mg 26-03-08
+ Guiaphenasin 100mg
+ Terbutaline sulphate 2.5mg
per 10ml syrup
For symptomatic relief of bronchospasm in bronchial
asthma and chronic bronchitis
177. Ambroxol 18-08-08
+Loratidine
+Guiaphensesin syrup (30mg+ 5mg+50mg per 5ml)
For the treatment of productive cough
Mucolytic therapy in acute and chronic diseases of the bronchi
Approved by (DCI) Drug Controller GENERAL - India For Marketing
( Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ambroxyl Hcl 1-12-1995
Acute and chronic disease of the respiratory tract associated with
bronchial secretions in particular acute attacks of chronic bronchitis
asthamatic bronchitis, bronchial asthma
2.Ambroxyl+ Loratidine + Guiaphenesin syrup 18-08-2008
(30mg+5mg)/ 5ml per 5ml
For the treatment of productive cough
3.Ambroxyl 30mg + Terbutaline 2.5mg + 27-10-2009
Guiaphenesin 100mg+ Menthol 2.5mg/ 5ml syrup
Additional strength
4.Ambroxyl 30mg + Levo salbutamol 1mg + 19-03-2009
Guiaphensin 50mg/5ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma
and chronic bronchitis
5.Ambroxyl Hcl 30mg +Guiaphenesin 100mg+ 26-03-2008
Terbutaline sulphate 2.5mg/10ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma
in chronic bronchitis
6.Ambroxol Hcl 15mg + Guiaphenesin 50mg + 26-03-2008
Terbutaline sulphate 1.25mg +
Menthol 2.5mg/ /5ml of syrup
For the symptomatic relief of bronchospasm in bronchial asthma
and chronic bronchitis
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Ambroxol Hcl SR 7.5mg+ 23-08-2001
Doxycycline Hcl 100mg tablet
Acute and chronic illness of RT with pathological inspiration of
mucous ( in case of acute attacks of chronic bronchitis, inflammation
of the prenasal sinuses) caused by doxycycline sensitive actiological
agents
2.Ambroxol 30mg + 29-10-1999
Guaiphenesin 100mg +
Menthol 1mg +
Pseudoephedrine 60mg 5ml syrup
Cough congestion
3.Ambroxol Hcl 15mg+ 18-08-2000
Guaiohensesin 100mg +
Ethanol 95% eq. to Ethanol 5% w/v per 5ml liquid
For treatment of cough
4.Ambroxol Hcl 15mg + 16-06-1999
Sabutamol 1mg+
Guiaphenesin 50mg+
Menthol 1mg per 5ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma
and chronic bronchitis
5.Ambroxol Hcl 30mg+ 20-03-2008
Guiaphenesin 100mg+
Terbutaline sulphate 2.5mg pr 10ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma and
chronic bronchitis
6.Ambroxol Hcl 30mg + 10-09-2001
Guiaphenesin 200mg tablet
For cough and congestion
7. Ambroxol Hcl 75mg SR + 11-10-2005
Desloratadine 5mg capsule
For the relief of productive cough
8.Ambroxol + 26-02-1998
Pseudoeohedrine +
Chloramine maleate tabs/suspn/syrup
For the symptomatic relief of bronchospasm in bronchial asthma
and chronic bronchitis
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Manufacturer Details