RecallHawk

GUAIFENESIN AND PSEUDOEPHEDRINE HCL

GRANULES

Summary

FDA approved GUAIFENESIN AND PSEUDOEPHEDRINE HCL by GRANULES. ANDA (Generic) approval on 2022-08-22. TABLET, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

ANDA216082-1

Action Date

2022-08-22

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

GUAIFENESIN AND PSEUDOEPHEDRINE HCL, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA216082

Company

Context & Analysis

GRANULES has 21 FDA actions in our database.

Frequently Asked Questions

How often does GRANULES have FDA actions?

GRANULES has 21 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 "ANDA216082-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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