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FDA Drug Application 050141 by KING PHARMS

Application Number050141
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
AP06/27/1952N       
AP05/27/1983SLR       
AP07/8/1983SLR       
AP07/29/1985SLR       
AP011/18/1985SLR       
AP012/5/1986SLR       
AP012/8/1986SLR       
AP011/17/1987SLR       
AP09/28/1987SLR       
AP05/3/1988SCE       
AP05/16/1988SLR       
AP06/16/1988SCG       
AP05/31/1989SLR       
AP06/16/1988SCE       
AP012/5/1952SLR       
AP012/5/1952SLR       
AP01/22/1953SLR       
AP05/26/1953SLR       
AP07/31/1953SLR       
AP012/9/1953SCE       
AP01/6/1954SLR       
AP04/2/1954SCE       
AP010/21/1954SE1       
AP011/16/1954SCF       
AP011/16/1954SCF       
AP011/8/1954SLR       
AP011/8/1954SLR       
AP02/2/1955SE1       
AP02/8/1955SLR       
AP04/1/1955SLR       
AP05/10/1955SLR       
AP05/26/1955SLR       
AP06/22/1955SE1       
AP010/1/1956SLR       
AP06/16/1988SCF       
AP012/22/1960SLR       
AP010/3/1960SLR       
AP012/22/1960SLR       
AP03/30/1961SLR       
AP03/20/1961SLR       
AP03/21/1961SLR       
AP05/2/1961SLR       
AP03/24/1961SLR       
AP03/31/1961SLR       
AP04/5/1961SLR       
AP04/5/1961SLR       
AP06/16/1961SLR       
AP06/16/1961SLR       
AP07/10/1961SLR       
AP08/4/1961SLR       
AP08/4/1961SLR       
AP01/15/1962SLR       
AP03/23/1963SLR       
AP05/23/1963SLR       
AP010/12/1962SCE       
AP012/19/1962SLR       
AP012/19/1962SLR       
AP04/5/1963SLR       
AP04/5/1963SLR       
AP05/28/1963SLR       
AP07/10/1963SLR       
AP07/11/1963SLR       
AP07/11/1963SLR       
AP07/31/1963SLR       
AP09/6/1963SLR       
AP09/6/1963SLR       
AP09/3/1963SLR       
AP09/24/1963SLR       
AP09/18/1963SLR       
AP09/25/1963SLR       
AP010/18/1963SLR       
AP010/16/1963SLR       
AP010/16/1963SLR       
AP012/9/1963SLR       
AP011/22/1963SLR       
AP012/26/1963SLR       
AP02/10/1964SLR       
AP04/29/1964SLR       
AP07/13/1964SLR       
AP08/13/1964SLR       
AP010/7/1964SLR       
AP010/15/1964SLR       
AP011/17/1964SLR       
AP01/22/1965SLR       
AP03/9/1965SLR       
AP03/31/1965SLR       
AP03/31/1965SLR       
AP05/6/1965SLR       
AP09/15/1965SLR       
AP010/28/1965SLR       
AP011/2/1965SLR       
AP011/3/1965SLR       
AP012/13/1965SLR       
AP02/8/1966SLR       
AP02/15/1966SLR       
AP03/2/1966SLR       
AP03/7/1966SLR       
AP03/15/1966SLR       
AP05/10/1966SLR       
AP05/16/1966SLR       
AP06/27/1966SLR       
AP07/6/1966SLR       
AP01/20/1967SLR       
AP02/24/1967SLR       
AP03/17/1967SLR       
AP03/29/1967SLR       
AP04/6/1967SLR       
AP04/14/1967SCF       
AP04/17/1967SLR       
AP04/19/1967SLR       
AP05/1/1967SLR       
AP05/5/1967SLR       
AP05/23/1967SLR       
AP06/1/1967SLR       
AP08/11/1967SLR       
AP011/22/1967SLR       
AP02/6/1968SLR       
AP02/29/1968SLR       
AP06/5/1968SLR       
AP08/26/1968SLR       
AP09/25/1968SLR       
AP09/25/1968SLR       
AP010/9/1968SLR       
AP010/31/1968SLR       
AP011/8/1968SLR       
AP011/5/1968SLR       
AP011/26/1968SLR       
AP012/26/1968SLR       
AP01/3/1969SLR       
AP01/3/1969SLR       
AP012/26/1968SLR       
AP01/30/1969SLR       
AP02/19/1969SLR       
AP04/10/1969SCE       
AP05/9/1969SLR       
AP07/24/1969SCE       
AP07/24/1969SCE       
AP08/5/1969SCE       
AP08/11/1969SCE       
AP010/23/1969SCE       
AP012/3/1969SLR       
AP012/31/1969SLR       
AP01/8/1970SLR       
AP01/8/1970SLR       
AP01/15/1970SCE       
AP01/27/1970SCE       
AP02/4/1970SCE       
AP02/16/1970SCE       
AP03/27/1970SLR       
AP04/10/1970SLR       
AP04/24/1970SLR       
AP04/27/1970SLR       
AP05/25/1970SLR       
AP05/27/1970SLR       
AP09/21/1970SLR       
AP010/14/1970SLR       
AP010/19/1970SLR       
AP010/24/1970SLR       
AP011/24/1970SLR       
AP01/19/1971SLR       
AP05/18/1971SLR       
AP06/10/1971SLR       
AP011/10/1971SLR       
AP04/20/1972SLR       
AP06/16/1972SLR       
AP07/25/1972SLR       
AP09/18/1972SLR       
AP09/11/1973SLR       
AP09/11/1973SLR       
AP09/11/1973SLR       
AP010/5/1973SLR       
AP011/12/1973SLR       
AP011/27/1973SLR       
AP011/24/1974SLR       
AP04/11/1974SLR       
AP04/11/1974SLR       
AP05/13/1974SLR       
AP06/20/1974SCF       
AP010/25/1974SLR       
AP011/19/1974SLR       
AP011/19/1974SLR       
AP011/19/1974SLR       
AP011/19/1974SLR       
AP01/9/1975SLR       
AP03/4/1975SLR       
AP07/15/1975SLR       
AP010/3/1975SLR       
AP011/5/1975SLR       
AP01/27/1976SLR       
AP02/10/1976SLR       
AP02/10/1976SLR       
AP02/10/1976SLR       
AP06/7/1976SLR       
AP06/10/1976SLR       
AP011/3/1976SLR       
AP07/27/1978SLR       
AP05/15/1980SLR       
AP012/21/1981SPD       
AP07/28/1982SLR       
AP09/16/1982SE2       
AP09/16/1982SLR       
AP08/31/1993SCP       
AP09/22/1993SLR       
AP03/1/2002SLR4401215   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50141s215ltr.pdf 3/1/2002
AP01/8/1998SCS       
AP03/23/2001SCS       
AP04/29/2002SLR4404218   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf 4/29/2002
AP04/29/2002SLR4405219   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf 4/29/2002
AP011/17/2005SLR13105224   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf 11/18/2005
AP012/18/2009SLR24338226   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050141s226lbl.pdf 12/22/2009
AP012/18/2009SLR24379226   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf 12/31/2009
AP09/6/2012SLR33681231   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf 9/7/2012
AP09/6/2012SLR33711231   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050141s231lbl.pdf 9/11/2012
AP04/25/2014SLR39159232   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050138Orig1s235,050141Orig1s232ltr.pdf 4/29/2014
AP04/25/2014SLR39287232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf 5/12/2014
AP010/13/2015SLR44201233   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050141Orig1s233ltr.pdf 10/14/2015
AP010/13/2015SLR44208233   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050141s233lbl.pdf 10/15/2015




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