Venlafaxine hydrochloride capsule, extended release

Ingredients and appearance - Product information

Venlafaxine hydrochloride capsule, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 42708-054
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Venlafaxine hydrochloride ( UNII: 7D7RX5A8MO)( Venlafaxine - UNII: GRZ5RCB1QG ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcellulose (7 mpa.s) ( UNII: H3UP11403C)
Gelatin, unspecified ( UNII: 2G86QN327L)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Povidone k30 ( UNII: U725QWY32X)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sucrose ( UNII: C151H8M554)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Potassium hydroxide ( UNII: WZH3C48M4T)

Product Characteristics

Color BROWN (buff) Size 19 mm
Shape CAPSULE Score 1
Imprint Code 93;7385;93;7385

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076565 USA

Labeler - QPharma Inc( 030620888)

Establishment

Name ID/FEI Business Operations
QPharma Inc 030620888 REPACK( 42708-054)
p < 0.001 versus placebo
p = 0.041
The discontinuation rates for weight loss were 0.7% for patients receiving either venlafaxine hydrochloride extended-release capsules or placebo.
In addition, in the premarketing assessment of venlafaxine tablets, multiple doses were administered to 2,897 patients in studies for MDD.
Percentages based on the number of men (venlafaxine hydrochloride extended-release capsules, n = 1,440; placebo, n = 923)
Percentages based on the number of women (venlafaxine hydrochloride extended-release capsules, n = 2,118; placebo, n = 1,274)
In addition, in the premarketing assessment of venlafaxine tablets (immediate release), 12% (357/2,897) of patients were 65 years of age.
Difference (drug minus placebo) in least-squares mean change from baseline
Doses statistically significantly superior to placebo.
Difference (drug minus placebo) in least-squares mean change from baseline
Difference (drug minus placebo) in least-squares mean change from baseline
Odds ratio (drug to placebo) in terms of probability of free of full-symptom panic attacks based on logistic regression model.

95%CI: 95% confidence interval without adjusting for multiple dose arms.
Doses statistically significantly superior to placebo.