FDA.reportPublic FDA data

Application 090747

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTION3MG/ML;EQ 3MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0720Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0791Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0791Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0799Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
0517-0799Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAmerican Regent, Inc.ANDACurrent
40042-048Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetatePharmaForce, Inc.ANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
53225-3665ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetateTerrain PharmaceuticalsANDACurrent
68788-7327ReadySharp BetamethasoneBetamethasone Sodium Phosphate and Betamethasone AcetatePreferred Pharmaceuticals Inc.ANDACurrent
69263-805BSP 0820Betamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-805BSP 0820Betamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
69263-822Beta 1 KitBetamethasone Sodium Phosphate, Betamethasone AcetateOaklock, LLCANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
70518-0506Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.ANDACurrent
76420-007Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAsclemed USA, Inc.ANDACurrent
76420-007Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateAsclemed USA, Inc.ANDACurrent