FDA.reportPublic FDA data

Application 080027

Type
ANDA
Sponsor
ALCON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALCAINEPROPARACAINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0998-0016Alcaineproparacaine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0998-0016Alcaineproparacaine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0998-0016Alcaineproparacaine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0998-0016Alcaineproparacaine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0998-0016Alcaineproparacaine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
50090-1931Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1931Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
61314-016Proparacaine HydrochlorideProparacaine HydrochlorideSandoz Inc.ANDACurrent
61314-016Proparacaine HydrochlorideProparacaine HydrochlorideSandoz Inc.ANDACurrent
61314-016Proparacaine HydrochlorideProparacaine HydrochlorideSandoz Inc.ANDACurrent
61314-016Proparacaine HydrochlorideProparacaine HydrochlorideSandoz Inc.ANDACurrent
68071-4701Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4701Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4701Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5139proparacaine hydrochlorideproparacaine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5139proparacaine hydrochlorideproparacaine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3408Proparacaine HydrochlorideProparacaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3408Proparacaine HydrochlorideProparacaine HydrochlorideREMEDYREPACK INC.ANDACurrent