Application 211302

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYSTADROPS	CYSTEAMINE OPHTHALMIC SOLUTION	SOLUTION; OPHTHALMIC	3.8 MG/ML	No	No

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
N211302-001	CYSTADROPS	CYSTEAMINE HYDROCHLORIDE	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2020-08-19

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	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211302-001	CYSTADROPS	EQ 0.37% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-08-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211302-001	NP	2023-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211302-001	NP	2023-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211302-001	NP	2023-08-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211302-001	NP	2023-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211302-001	NP	2023-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211302-001	NP	2023-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211302-001	NP	2023-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211302-001	NP	2023-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211302-001	NP	2023-08-19	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N211302-001	NP	2023-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211302-001	NP	2023-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211302-001	NP	2023-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211302-001	NP	2023-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211302-001	NP	2023-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211302-001	NP	2023-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211302-001	NP	2023-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211302-001	NP	2023-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211302-001	NP	2023-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211302-001	NP	2023-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211302-001	NP	2023-08-19	`cb3db0bc1861…`

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
CYSTADROPS	CYSTEAMINE HYDROCHLORIDE	RECORDATI RARE DISEASES, INC.	5d2bcce3-9b89-4141-aeb7-db00449047f5	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211302 application number: NDA211302 ndc (product): 55292-410

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-410	CYSTADROPS	cysteamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-410	CYSTADROPS	cysteamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67441	ORIG	2021-05-07
64323	ORIG	2020-08-20
64322	ORIG	2020-08-20