FDA.reportPublic FDA data

Application 040075

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTOLAIRCYCLOPENTOLATE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-735Cyclopentolate HydrochlorideCyclopentolate HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-735Cyclopentolate HydrochlorideCyclopentolate HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-735Cyclopentolate HydrochlorideCyclopentolate HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-735Cyclopentolate HydrochlorideCyclopentolate HydrochlorideBausch & Lomb IncorporatedANDACurrent
24208-735Cyclopentolate HydrochlorideCyclopentolate HydrochlorideBausch & Lomb IncorporatedANDACurrent
42254-013Cyclopentolate HydrochlorideCyclopentolate HydrochlorideRebel Distributors CorpANDACurrent