FDA.reportPublic FDA data

Application 040074

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-530Proparacaine HydrochlorideProparacaine HydrochlorideRebel Distributors CorpANDACurrent
24208-730Proparacaine HydrochlorideProparacaine HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-730Proparacaine HydrochlorideProparacaine HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-730Proparacaine HydrochlorideProparacaine HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-730Proparacaine HydrochlorideProparacaine HydrochlorideBausch & Lomb IncorporatedANDACurrent
50090-1923Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1923Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1923Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
52959-705Proparacaine HydrochlorideProparacaine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68071-1332Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4368Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4368Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4368Proparacaine HydrochlorideProparacaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0736Proparacaine HydrochlorideProparacaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent