Vericiguat ANDA, Torrent Pharma, Tentative Approval, 20th Apr
Summary
Torrent Pharmaceuticals Ltd received FDA tentative approval for Vericiguat tablets in three strengths (2.5mg, 5mg, 10mg) under ANDA 220221. The FDA recorded the action on April 20, 2026. Marketing status is listed as None (Tentative Approval), meaning commercial distribution cannot begin until final approval or until applicable patent and exclusivity periods expire.
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GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 9 changes logged to date.
What changed
The FDA granted tentative approval to Torrent Pharmaceuticals Ltd for Vericiguat (VERICIGUAT) tablets in 2.5mg, 5mg, and 10mg strengths under ANDA 220221, recorded on April 20, 2026. The drug was not designated as Reference Listed Drug (RLD) or Reference Standard (RS), and no therapeutic equivalence (TE) code was assigned.
Affected parties (generic pharmaceutical manufacturers and applicants) should note that tentative approval does not authorize commercial marketing. Distribution of Vericiguat generic tablets cannot commence until final approval is granted or the relevant patents and exclusivity protections on the reference listed drug expire.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 220221
Company: TORRENT PHARMACEUTICALS LTD
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERICIGUAT | VERICIGUAT | 5MG | TABLET | None (Tentative Approval) | None | No | No |
| VERICIGUAT | VERICIGUAT | 2.5MG | TABLET | None (Tentative Approval) | None | No | No |
| VERICIGUAT | VERICIGUAT | 10MG | TABLET | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/20/2026 | ORIG-1 | Tentative Approval | STANDARD | Label is not available on this site. |
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