Application 217307

Type: NDA
Sponsor: THEA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLYMBUS	BIMATOPROST	GEL;OPHTHALMIC	0.01%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N217307-001	ZOLYMBUS	BIMATOPROST	0.01%	GEL / OPHTHALMIC		RLD, RS	2025-09-09

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217307-001	NDF	2028-09-09

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
2026-02-19 14:30 UTC	2026-02	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`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
2026-02-19 14:30 UTC	2026-02	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217307-001	NDF	2028-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	NDF	2028-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	NDF	2028-09-09	`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
ZOLYMBUS	BIMATOPROST	Thea Pharma Inc.	f4504a0c-7998-4084-9e05-f999f1d051ed	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217307 application number: NDA217307

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83316	ORIG	2025-09-11
83310	ORIG	2025-09-09