Back to FDA Applications sponsored by KING PHARMS

FDA Drug Application 050138 by KING PHARMS

Application Number050138
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1953N       
AP09/8/1953SLR       
AP09/9/1953SLR       
AP011/19/1953SLR       
AP011/19/1953SLR       
AP03/9/1954SLR       
AP04/5/1954SCE       
AP09/13/1954SCE       
AP012/6/1954SLR       
AP05/4/1955SLR       
AP05/26/1955SLR       
AP06/16/1988SCG       
AP09/9/1993SCP       
AP07/15/1955SCE       
AP012/6/1955SLR       
AP09/24/1956SLR       
AP010/5/1956SLR       
AP011/20/1956SLR       
AP09/20/1962SLR       
AP010/26/1960SLR       
AP09/20/1962SLR       
AP01/4/1963SLR       
AP03/20/1961SLR       
AP03/20/1961SLR       
AP03/21/1961SLR       
AP03/31/1961SLR       
AP04/5/1961SLR       
AP06/7/1961SLR       
AP08/4/1961SLR       
AP08/4/1961SLR       
AP09/25/1961SCE       
AP03/9/1962SLR       
AP03/16/1962SLR       
AP03/23/1962SLR       
AP08/1/1962SLR       
AP010/11/1962SLR       
AP012/19/1962SLR       
AP011/28/1962SLR       
AP01/4/1963SLR       
AP01/29/1963SLR       
AP05/28/1963SLR       
AP07/11/1963SLR       
AP07/31/1963SLR       
AP012/10/1963SLR       
AP010/7/1963SLR       
AP09/25/1963SLR       
AP09/18/1963SLR       
AP09/18/1963SLR       
AP011/15/1963SLR       
AP012/23/1963SLR       
AP06/3/1964SLR       
AP010/21/1964SLR       
AP02/1/1965SCE       
AP011/17/1964SCM       
AP011/19/1964SCM       
AP01/7/1965SLR       
AP01/22/1965SLR       
AP03/31/1965SCM       
AP05/7/1965SLR       
AP06/25/1965SLR       
AP08/12/1965SLR       
AP09/10/1965SLR       
AP01/6/1966SLR       
AP02/8/1966SLR       
AP02/4/1966SCM       
AP02/14/1966SLR       
AP03/11/1966SLR       
AP03/18/1966SLR       
AP04/6/1966SLR       
AP04/8/1966SLR       
AP04/22/1966SLR       
AP06/10/1966SLR       
AP07/19/1966SLR       
AP08/26/1966SLR       
AP08/25/1966SLR       
AP09/2/1966SLR       
AP09/28/1966SLR       
AP011/3/1966SLR       
AP012/8/1966SCM       
AP03/7/1967SLR       
AP03/17/1967SLR       
AP03/27/1967SLR       
AP03/29/1967SLR       
AP04/14/1967SCM       
AP04/4/1967SLR       
AP04/19/1967SLR       
AP04/14/1967SCE       
AP04/20/1967SLR       
AP04/24/1967SLR       
AP04/25/1967SLR       
AP06/30/1967SLR       
AP07/18/1967SLR       
AP08/23/1967SLR       
AP08/29/1967SLR       
AP09/8/1967SLR       
AP010/10/1967SLR       
AP01/4/1968SLR       
AP03/22/1968SLR       
AP06/17/1968SLR       
AP08/2/1968SLR       
AP08/2/1968SLR       
AP08/22/1968SLR       
AP08/23/1968SLR       
AP09/3/1968SLR       
AP010/29/1968SLR       
AP011/5/1968SLR       
AP011/19/1968SLR       
AP012/2/1968SLR       
AP012/12/1968SLR       
AP01/30/1969SCM       
AP09/4/1969SCE       
AP07/17/1969SLR       
AP08/4/1969SLR       
AP011/4/1969SCE       
AP010/27/1969SLR       
AP011/4/1969SLR       
AP011/24/1969SLR       
AP012/4/1969SLR       
AP012/11/1969SLR       
AP012/18/1969SLR       
AP012/30/1969SLR       
AP01/8/1970SCM       
AP03/27/1970SLR       
AP04/2/1970SLR       
AP04/14/1970SCS       
AP04/27/1970SLR       
AP05/27/1970SLR       
AP012/11/1970SLR       
AP011/24/1970SCS       
AP011/24/1970SCS       
AP012/11/1970SLR       
AP01/19/1971SLR       
AP01/19/1971SLR       
AP01/27/1971SLR       
AP03/1/1971SLR       
AP05/18/1971SLR       
AP02/2/1972SLR       
AP07/25/1972SLR       
AP08/7/1972SLR       
AP09/5/1972SLR       
AP010/26/1972SLR       
AP011/22/1972SCM       
AP02/26/1973SLR       
AP03/7/1973SLR       
AP05/18/1973SPD       
AP05/15/1973SLR       
AP05/18/1973SLR       
AP05/30/1973SLR       
AP06/21/1973SLR       
AP07/31/1973SLR       
AP08/1/1973SLR       
AP09/11/1973SLR       
AP09/14/1973SLR       
AP011/12/1973SLR       
AP011/13/1973SLR       
AP011/23/1973SLR       
AP012/7/1973SLR       
AP03/8/1974SLR       
AP03/28/1974SLR       
AP04/11/1974SLR       
AP05/29/1974SLR       
AP06/7/1974SLR       
AP010/2/1974SLR       
AP010/2/1974SLR       
AP010/22/1974SLR       
AP011/19/1974SLR       
AP012/19/1974SLR       
AP02/25/1975SLR       
AP03/4/1975SCM       
AP03/21/1975SPD       
AP07/15/1975SLR       
AP012/25/1975SLR       
AP09/10/1975SLR       
AP011/5/1975SLR       
AP011/21/1975SLR       
AP012/23/1975SLR       
AP01/27/1976SLR       
AP02/10/1976SLR       
AP02/19/1976SLR       
AP03/23/1976SLR       
AP04/16/1976SLR       
AP06/7/1976SLR       
AP06/10/1976SLR       
AP011/3/1976SLR       
AP011/5/1976SLR       
AP01/11/1977SLR       
AP06/2/1977SLR       
AP010/14/1977SLR       
AP04/24/1978SCS       
AP05/24/1979SLR       
AP07/27/1979SLR       
AP05/15/1980SLR       
AP012/14/1981SLR       
AP012/21/1981SLR       
AP07/16/1982SLR       
AP07/28/1982SLR       
AP07/28/1983SLR       
AP07/19/1983SLR       
AP010/12/1983SLR       
AP011/18/1985SCS       
AP012/5/1986SLR       
AP012/5/1986SLR       
AP012/8/1986SCP       
AP09/28/1987SLR       
AP011/17/1987SLR       
AP04/14/1988SCS       
AP05/16/1988SLR       
AP06/16/1988SCP       
AP05/31/1989SLR       
AP05/31/1989SLR       
AP05/31/1989SLR       
AP09/22/1993SLR       
AP03/1/2002SLR8793219   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s219ltr.pdf 5/28/2004
AP011/25/1997SCS       
AP03/23/2001SCS       
AP04/29/2002SLR4402222   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf 4/29/2002
AP04/29/2002SLR4403223   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf 4/29/2002
AP012/22/2004SLR10827228   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50138s228ltr.pdf 12/29/2004
AP011/17/2005SLR13106229   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf 11/18/2005
AP012/18/2009SLR24337231   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf 12/22/2009
AP012/18/2009SLR24378231   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf 12/31/2009
AP09/6/2012SLR33680234   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf 9/7/2012
AP09/6/2012SLR33712234   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf 9/11/2012
AP04/25/2014SLR39160235   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050138Orig1s235,050141Orig1s232ltr.pdf 4/29/2014
AP04/25/2014SLR39288235   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf 5/12/2014
AP010/13/2015SLR44200236   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050138Orig1s236ltr.pdf 10/14/2015
AP010/13/2015SLR44209236   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050138s236lbl.pdf 10/15/2015




Back to FDA Applications sponsored by KING PHARMS