Details for New Drug Application (NDA): 217390
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NDA 217390 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Swiss Pharm, Unique, Zydus Pharms, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-five NDAs. It is available from sixty-five suppliers. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.
The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 217390
| Tradename: | VENLAFAXINE HYDROCHLORIDE |
| Applicant: | Granules |
| Ingredient: | venlafaxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217390
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 217390
Suppliers and Packaging for NDA: 217390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 217390 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8509 | 0615-8509-39 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8509-39) |
| VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 217390 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8510 | 0615-8510-39 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8510-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | May 18, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | May 18, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | May 18, 2023 | TE: | AB | RLD: | No | ||||
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