RecallHawk

JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)

DR REDDYS

Summary

FDA approved JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) by DR REDDYS. ANDA (Generic) approval (Labeling) on 2025-01-24. FOR SOLUTION, ORAL.

Details

Source

Drug Approval

External ID

ANDA209452-8

Action Date

2025-01-24

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

JAVYGTOR (generic: SAPROPTERIN DIHYDROCHLORIDE), FOR SOLUTION, ORAL. Application: ANDA209452

Company

Context & Analysis

DR REDDYS has 47 FDA actions in our database.

Frequently Asked Questions

How often does DR REDDYS have FDA actions?

DR REDDYS has 47 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "ANDA209452-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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