Regulations.gov document
Attachment 1 - Current (October 06, 2023) Orange Book Listing of RLD TRANDATE® (Labetalol…
Supporting & Related Material · FDA-2023-P-4552 · posted Oct 17, 2023
Key facts
| Document ID | FDA-2023-P-4552-0003 |
|---|---|
| Title | Attachment 1 - Current (October 06, 2023) Orange Book Listing of RLD TRANDATE® (Labetalol Hydrochloride) Injection USP, 5 mg/mL, NDA #019425, held by Sebela Ireland LTD.RE Suitability Petition from Nines Consult Pharma, LLC |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2023-P-4552 |
| Posted | Oct 17, 2023 |
At a glance
- None Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Regulations.gov documents
Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.
Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date: