VENLAFAXINE HYDROCHLORIDE | N022104 | OSMOTICA PHARMACEUTICAL US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4954 · 9 docket documents Premier Consulting filed an amendment to its suitability petition seeking permission to file an ANDA for venlafaxine hydrochloride and venlafaxine hydrochloride oral liquid dosage form. The petitioner requests that the FDA complete review of the petition and determine that the proposed drug product | Suitability | 2024-11-13 | Granted | Premier Consulting |
Citizen Petition from Osmotica Pharmaceutical US LLC FDA-2016-P-4341 · 7 docket documents Osmotica Pharmaceutical US LLC filed this citizen petition on December 9, 2016, under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any abbreviated new drug application seeking approval of venlafaxine hydrochloride extended-release tablets at 225 mg that | 505(q) | 2016-12-13 | Denied | Osmotica Pharmaceutical US LLC |
Osmotica Pharmaceutical Corporation - Citizen Petition FDA-2012-P-0515 · 3 docket documents Osmotica Pharmaceutical Corporation filed this citizen petition under Federal Food, Drug, and Cosmetic Act section 505(q) requesting that FDA refuse to approve Sun Pharma Global Inc.'s supplement to ANDA No. 091272 for generic Venlafaxine Hydrochloride Extended-Release Tablets, 225 mg, if the tablet | 505(q) | 2012-05-28 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2003-P-0351 · 19 docket documents Lachman Consultant Services, Inc. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Venlafaxine Hydrochloride Extended-Release Tablets in 37.5 mg, 75 mg, and 150 mg strengths suitable for submission as an ANDA, with Eff | Other | 2008-08-13 | Granted | — |
Sun Pharmaceutical Industries, Ltd. - Citizen Petition FDA-2008-P-0247 · 3 docket documents Sun Pharmaceutical Industries, Ltd., through its United States agent Kendle Regulatory Affairs, filed this petition under section 505(j)(2)(C) requesting a determination that an Abbreviated New Drug Application may be submitted for Venlafaxine Hydrochloride Extended Release Oral Tablets at 225 mg an | Other | 2008-04-22 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5160
per ea
Lowest NADAC/Unit
$0.2367
per ea
Brand NDCs
0
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 13811071590VENLAFAXINE HCL ER 225 MG TAB | $0.5160 | EA | Generic | — | 2026-06-17 |
| 13811071530VENLAFAXINE HCL ER 225 MG TAB | $0.5160 | EA | Generic | — | 2026-06-17 |
| 13811071230VENLAFAXINE HCL ER 37.5 MG TAB | $0.4938 | EA | Generic | — | 2026-06-17 |
| 13811071290VENLAFAXINE HCL ER 37.5 MG TAB | $0.4938 | EA | Generic | — | 2026-06-17 |
| 13811071330VENLAFAXINE HCL ER 75 MG TAB | $0.2655 | EA | Generic | — | 2026-06-17 |
| 13811071390VENLAFAXINE HCL ER 75 MG TAB | $0.2655 | EA | Generic | — | 2026-06-17 |
| 13811071490VENLAFAXINE HCL ER 150 MG TAB | $0.2367 | EA | Generic | — | 2026-06-17 |
| 13811071430VENLAFAXINE HCL ER 150 MG TAB | $0.2367 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.