Details for New Drug Application (NDA): 214127
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The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 214127
Tradename: | VENLAFAXINE HYDROCHLORIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | venlafaxine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214127
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 214127
Suppliers and Packaging for NDA: 214127
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 214127 | ANDA | Ascend Laboratories, LLC | 67877-726 | 67877-726-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-726-30) |
VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 214127 | ANDA | Ascend Laboratories, LLC | 67877-726 | 67877-726-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-726-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
Approval Date: | Jun 10, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Jun 10, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Jun 10, 2021 | TE: | AB | RLD: | No |
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