Drug application
TYLENOL W/ CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE)
Drugs@FDA ANDA 085056 · ORTHO MCNEIL PHARM
Key facts
| Drug name | TYLENOL W/ CODEINE |
|---|---|
| Active ingredients | ACETAMINOPHEN, CODEINE PHOSPHATE |
| Application type | ANDA |
| Application number | 085056 |
| Company | ORTHO MCNEIL PHARM |
| Dosage forms | TABLET, ORAL |
| Strength | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Jul 9, 1976 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.