Application 216190

Type: NDA
Sponsor: FIDELITY BIOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONTRALFY	TIZANIDINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 2MG BASE/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216190-001	ONTRALFY	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE/5ML	SOLUTION / ORAL		RLD, RS	2024-12-12

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19
N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ontralfy	TIZANIDINE HYDROCHLORIDE	Rosemont Pharmaceuticals, LLC	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2025-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216190 application number: NDA216190

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83125	ORIG	2025-08-19
80583	ORIG	2024-12-16
80572	ORIG	2024-12-13