FDA.reportPublic FDA data

Application 076622

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OFLOXACINOFLOXACINSOLUTION/DROPS;OPHTHALMIC0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-439OfloxacinOfloxacinRebel Distributors CorpANDACurrent
24208-434OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
24208-434OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
24208-434OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
24208-434OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
24208-434OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
50436-6112OfloxacinOfloxacinUnit Dose ServicesANDACurrent
63187-268OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-268OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-268OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-268OfloxacinOfloxacinProficient Rx LPANDACurrent
68071-2254OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2254OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2265OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2265OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7693OfloxacinOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7693OfloxacinOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7693OfloxacinOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9204OfloxacinOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3573OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43091ORIG2012-03-28
8935ORIG2004-05-26