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Product NDC
55316-144
11-digit product format
553160144
Labeler code
55316
Product ID
55316-144_2f10a19c-4e4a-45b5-922c-f3f41130cc8d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, pseudoephedrine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DZA Brands LLC
Application
ANDA091071
Marketing category
ANDA
Marketing start
2016-08-25
Marketing end
0000-00-00
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record