Drugs@FDA document
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE REMS · ANDA 209069 ORIG-1
Drugs@FDA document · WES PHARMA INC · Nov 6, 2023
Key facts
| Drug name | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
|---|---|
| Document type | REMS |
| Application | ANDA209069 |
| Submission | ORIG-1 |
| Company | WES PHARMA INC |
| Document date | Nov 6, 2023 |
| FDA document | accessdata.fda.gov |
At a glance
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About Drugs@FDA documents
Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date: