arketing End Date
ANDA ANDA090774 12/11/2013
DULOXETINE HYDROCHLORIDE
duloxetin hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-111
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE 60 mg
Inactive Ingredients
Ingredient Name
Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
Product Characteristics
Color BLUE (opaque blue cap and yellow body) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 60;1111
Contains
Packaging
Item Code
Package Description
Marketing Start Dat
Marketing End Date
1.NDC:13668-111-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2013
2.NDC:13668-111-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2013
3NDC:13668-111-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2013
4NDC:13668-111-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2013
5NDC:13668-111-74 100 in 1 CARTON; Type 0: Not a Combination Product 12/11/2013
Marketing Information
Marketing Category
Application Number or Monograph Citation
Mar
Marketing End Date
ANDA ANDA090774 12/11/2013
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