STERINOVA INC: Generic drug approval for NALOXONE HYDROCHLORIDE

STERINOVA INC: Generic drug approval for NALOXONE HYDROCHLORIDE. Dated 79 days ago, it serves as a historical benchmark. Score 45/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorSTERINOVA INC
ProductNALOXONE HYDROCHLORIDE
Generic / ingredientNALOXONE HYDROCHLORIDE
ApprovalGeneric drug approval (ANDA)
ApplicationANDA219942
Decided2026-08-18
Panel / classINJECTABLE, INJECTION
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-08-18
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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45 / 100 Score

  • A generic launch.

What is the FdaApprovalPulse record for STERINOVA INC?

The FDA approved NALOXONE HYDROCHLORIDE (ANDA219942) for STERINOVA INC on 2026-08-18: generic drug approval (ANDA).

How does STERINOVA INC compare to other FdaApprovalPulse records?

It is 79 days old; check the official source for later updates before acting.

STERINOVA INC vs. top 3 peers

OrganizationRecord date
STERINOVA INC2026-08-18
ALEMBIC2026-10-28
NEURORX2026-10-28
ALEMBIC2026-10-26

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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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