FDA.reportPublic FDA data

Application 020923

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPTIRAY 240IOVERSOLINJECTABLE;INJECTION51%NoNo
002OPTIRAY 320IOVERSOLINJECTABLE;INJECTION68%YesYes
003OPTIRAY 350IOVERSOLINJECTABLE;INJECTION74%YesYes
004OPTIRAY 300IOVERSOLINJECTABLE;INJECTION64%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1332OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74088SUPPL 2023-04-27
74076SUPPL 2023-04-27
70228SUPPL2022-02-23
70218SUPPL2022-02-22
65293SUPPL2020-11-19
65288SUPPL2020-11-19
65286SUPPL2020-11-19
65285SUPPL2020-11-19
50743SUPPL2017-12-18
50678SUPPL2017-12-13
48210SUPPL2017-05-02
48136SUPPL2017-04-27
47962SUPPL2017-04-12
47876SUPPL2017-04-06
45075SUPPL2016-08-17
45132SUPPL2016-08-12
3762SUPPL2015-07-10
35652SUPPL2015-07-09
41814ORIG2004-03-09
35651ORIG1998-05-29
3761ORIG1998-05-28