Basic Information
Sertraline hydrochloride
70010-204
Regulatory Information
70010-204
ANDA078403
C73584
April 6, 2023
USA
Sertraline Hydrochloride tablets 25 mg, 50 mg, and 100 mg Tablets
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
079825711
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Code: 2165RE0K14
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A
Code: H8AV0SQX4D
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
POLYETHYLENE GLYCOL 400
Code: B697894SGQ
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
Code: L11K75P92J
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
Active Moieties
SERTRALINE
Code: QUC7NX6WMB