Application 021640

Type
BLA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITRASEHYALURONIDASEINJECTABLE;INJECTION6,200 UNITS/VIALNoNo
002VITRASEHYALURONIDASEINJECTABLE;INJECTION200 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedBLACurrent
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedNDACurrent
24208-002VITRASEhyaluronidase, ovineBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77226SUPPL 2024-01-16
77216SUPPL 2024-01-16
62382APPL2020-03-31
54376SUPPL2020-03-23
54371SUPPL2020-03-23
44482ORIG2020-03-23
37380SUPPL2020-03-23
37379SUPPL2020-03-23
37378SUPPL2020-03-23
37377SUPPL2020-03-23
37376ORIG2020-03-23
28293SUPPL2020-03-23
28292SUPPL2020-03-23
28291SUPPL2020-03-23
28290ORIG2020-03-23
21764ORIG2020-03-23
5899SUPPL2020-03-23