Healthy Accents 12 Hour Nasal Decongestant
- Product NDC
- 55316-054
- 11-digit product format
- 553160054
- Labeler code
- 55316
- Product ID
- 55316-054_547c484f-4d1e-461b-bdd9-731243c0ece2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- DZA Brands LLC
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2011-07-19
- Marketing end
- 2020-07-31
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record