Details for New Drug Application (NDA): 216232
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The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 216232
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Micro Labs |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216232
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 216232
Suppliers and Packaging for NDA: 216232
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 216232 | ANDA | Micro Labs Limited | 42571-387 | 42571-387-01 | 100 CAPSULE in 1 BOTTLE (42571-387-01) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 216232 | ANDA | Micro Labs Limited | 42571-387 | 42571-387-10 | 1000 CAPSULE in 1 BOTTLE (42571-387-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 29, 2022 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 29, 2022 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Mar 29, 2022 | TE: | AB | RLD: | No |
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