Details for New Drug Application (NDA): 216044
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NDA 216044 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Inventia Hlthcare, Macleods Pharms Ltd, Medicap Labs, Nostrum Pharms Llc, Orbion Pharms, Pharmobedient, Sciegen Pharms Inc, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Abon Pharms Llc, Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Mpp Pharma, 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-seven NDAs. It is available from sixty-three 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-five 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-five suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 216044
| Tradename: | VENLAFAXINE HYDROCHLORIDE |
| Applicant: | Unique |
| Ingredient: | venlafaxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216044
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 216044
Suppliers and Packaging for NDA: 216044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216044 | ANDA | Rising Pharma Holdings, Inc. | 64980-578 | 64980-578-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-578-03) |
| VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216044 | ANDA | Rising Pharma Holdings, Inc. | 64980-578 | 64980-578-09 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-578-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | Nov 28, 2022 | 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: | Nov 28, 2022 | 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: | Nov 28, 2022 | TE: | AB | RLD: | No | ||||
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