FDA.reportPublic FDA data

Application 090699

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEINJECTABLE;INJECTION5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-586Labetalol HydrochlorideLabetalol HydrochlorideAlvogen Inc.ANDACurrent
47781-586Labetalol HydrochlorideLabetalol HydrochlorideAlvogen Inc.ANDACurrent
47781-586Labetalol HydrochlorideLabetalol HydrochlorideAlvogen Inc.ANDACurrent
47781-586Labetalol HydrochlorideLabetalol HydrochlorideAlvogen Inc.ANDACurrent
51991-934Labetalol HydrochlorideLabetalol HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-934Labetalol HydrochlorideLabetalol HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-935Labetalol HydrochlorideLabetalol HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-935Labetalol HydrochlorideLabetalol HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
68083-111Labetalol HydrochlorideLabetalol HydrochlorideGland Pharma LimitedANDACurrent
68083-111Labetalol HydrochlorideLabetalol HydrochlorideGland Pharma LimitedANDACurrent
68083-111Labetalol HydrochlorideLabetalol HydrochlorideGland Pharma LimitedANDACurrent
72266-102Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-102Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-102Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-103Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-103Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-103Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72266-103Labetalol HydrochlorideLabetalol HydrochlorideFosun Pharma USA Inc.ANDACurrent
72611-734labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-734labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-734labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-734labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-738labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-738labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-738labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent
72611-738labetalol hydrochloridelabetalol hydrochlorideAlmaject, Inc.ANDACurrent