FDA.reportPublic FDA data

Application 077161

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-302amiodarone hydrochlorideamiodarone hydrochlorideSagent PharmaceuticalsANDACurrent
25021-302amiodarone hydrochlorideamiodarone hydrochlorideSagent PharmaceuticalsANDACurrent
25021-302amiodarone hydrochlorideamiodarone hydrochlorideSagent PharmaceuticalsANDACurrent
25021-302amiodarone hydrochlorideamiodarone hydrochlorideSagent PharmaceuticalsANDACurrent
68083-112Amiodarone hydrochlorideAmiodarone hydrochlorideGland Pharma LimitedANDACurrent
68083-112Amiodarone hydrochlorideAmiodarone hydrochlorideGland Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44343ORIG2005-07-28