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RegulatoryNot specifiedRegulatory Approval

TEVA Pharmaceuticals submits ANDA219413 for FDA review

The submission of ANDA219413 by TEVA Pharmaceuticals is significant as it represents a potential entry of a generic product into the market. This could alter pricing dynamics and competitive positioning within the relevant therapeutic area, which is currently unspecified.

Published: June 18, 2026
Updated: June 18, 2026
Author: Humanexa Intelligence
Therapeutic area: Not specified
Company: TEVA PHARMACEUTICALS, INC
Asset: ANDA219413
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval

Company

TEVA PHARMACEUTICALS, INC

Asset

ANDA219413

Indication

Not specified

Status

Approved

Signal Score

6.8

Signal assessment

Signal strength

moderate

Confidence level

moderate

Signalmoderate
Confidencemoderate

Strategic implication

The submission of ANDA219413 by TEVA Pharmaceuticals is significant as it represents a potential entry of a generic product into the market. This could alter pricing dynamics and competitive positioning within the relevant therapeutic area, which is currently unspecified.

Why it matters

The submission of ANDA219413 by TEVA Pharmaceuticals is significant as it represents a potential entry of a generic product into the market. This could alter pricing dynamics and competitive positioning within the relevant therapeutic area, which is currently unspecified.

What changed

Regulatory Approval

Analysis

TEVA Pharmaceuticals has submitted ANDA219413 to the FDA with a standard review priority.

The submission of ANDA219413 by TEVA Pharmaceuticals is significant as it represents a potential entry of a generic product into the market. This could alter pricing dynamics and competitive positioning within the relevant therapeutic area, which is currently unspecified.

Monitor the FDA's review timeline and any subsequent approval announcements for ANDA219413.

Related companies & assets

Companies

  • View signals for TEVA PHARMACEUTICALS, INC →

Assets

  • ANDA219413 →

Sources & Humanexa intelligence

Source links

  • FDA TA — ANDA219413 ↗
  • TEVA Pharmaceuticals submits ANDA219413 for FDA review ↗

Related Humanexa pages

  • TEVA Pharmaceuticals submits ANDA219413 for FDA review →

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