FDA.reportPublic FDA data

Application 019710

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPTIRAY 320IOVERSOLINJECTABLE;INJECTION68%YesYes
002OPTIRAY 240IOVERSOLINJECTABLE;INJECTION51%YesYes
003OPTIRAY 160IOVERSOLINJECTABLE;INJECTION34%NoNo
004OPTIRAY 300IOVERSOLINJECTABLE;INJECTION64%YesYes
005OPTIRAY 350IOVERSOLINJECTABLE;INJECTION74%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
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1323OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1324OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1324OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1324OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1324OptirayIoversolLiebel-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
0019-1332OptirayIoversolLiebel-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
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent
0019-1333OptirayIoversolLiebel-Flarsheim Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74087SUPPL 2023-04-27
74075SUPPL 2023-04-27
71021SUPPL2022-05-06
71002SUPPL2022-05-05
70227SUPPL2022-02-23
70217SUPPL2022-02-22
61644SUPPL2020-01-24
61631SUPPL2020-01-24
48211SUPPL2017-05-02
48135SUPPL2017-04-27
47963SUPPL2017-04-12
47877SUPPL2017-04-06
45076SUPPL2016-08-17
45131SUPPL2016-08-12
1519SUPPL2015-07-10
11643SUPPL2015-07-09
1518SUPPL2008-04-30
19111SUPPL2008-04-28
20300SUPPL1997-05-23