VENLAFAXINE HYDROCHLORIDE | N020699 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from SciRegs International, Inc (on behalf of Inventia Healt... FDA-2025-P-1304 · 5 docket documents SciRegs International Inc. on behalf of Inventia Healthcare Limited filed this citizen petition requesting that the FDA determine whether NDA 020699 Effexor-XR (venlafaxine HCl) Extended-Release Capsule 100 mg was withdrawn for reasons of safety or effectiveness under 21 CFR 314.122, in support of I | Other | 2025-05-19 | Granted | Inventia Healthcare Limited |
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 |
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may be submitted for Venlafaxine Hydrochloride Extended Release Oral Tablets at 225 mg an | Other | 2008-04-22 | Withdrawn | — |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
$21.59
per ea
Lowest NADAC/Unit
$17.70
per ea
Brand NDCs
7
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 58151012777EFFEXOR XR 150 MG CAPSULE | $21.59 | EA | Brand | $0.1169 | 2026-06-17 |
| 00008083621EFFEXOR XR 150 MG CAPSULE | $21.59 | EA | Brand | $0.1169 | 2026-06-17 |
| 58151012793EFFEXOR XR 150 MG CAPSULE | $21.59 | EA | Brand | $0.1169 | 2026-06-17 |
| 58151012677EFFEXOR XR 75 MG CAPSULE | $19.81 | EA | Brand | $0.0822 | 2026-06-17 |
| 58151012693EFFEXOR XR 75 MG CAPSULE | $19.81 | EA | Brand | $0.0822 | 2026-06-17 |
| 58151012593EFFEXOR XR 37.5 MG CAPSULE | $17.70 | EA | Brand | $0.0850 | 2026-06-17 |
| 58151012577EFFEXOR XR 37.5 MG CAPSULE | $17.70 | EA | Brand | $0.0850 | 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.