RecallHawk

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

PHARM ASSOC

Summary

FDA approved PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE by PHARM ASSOC. ANDA (Generic) approval (Labeling) on 2023-12-15. SYRUP, ORAL.

Details

Source

Drug Approval

External ID

ANDA089647-17

Action Date

2023-12-15

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, SYRUP, ORAL. Application: ANDA089647

Context & Analysis

PHARM ASSOC has 13 FDA actions in our database.

Frequently Asked Questions

How often does PHARM ASSOC have FDA actions?

PHARM ASSOC has 13 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 "ANDA089647-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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