Application 208010

Type: NDA
Sponsor: OPKO IRELAND GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAYALDEE	CALCIFEDIOL	CAPSULE, EXTENDED RELEASE;ORAL	0.03MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208010-001	RAYALDEE	CALCIFEDIOL	0.03MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2016-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208010-001	10213442	2027-02-02		Drug product	2019-03-06
N208010-001	8906410	2027-02-02		Drug product	2016-07-06
N208010-001	9943530	2027-02-02	U-2274		2018-05-01
N208010-001	11154509	2028-04-25	U-3815		2021-11-17
N208010-001	8207149	2028-04-25	U-1871		2016-07-06
N208010-001	8778373	2028-04-25	U-1873		2016-07-06
N208010-001	9408858	2028-04-25	U-1888		2016-08-16
N208010-001	9498486	2028-04-25	U-3814		2016-12-06
N208010-001	9925147	2028-04-25	U-2255	Drug product	2018-04-09
N208010-001	9925147	2028-04-25	U-2256	Drug product	2018-04-09
N208010-001	9925147	2028-04-25	U-2257	Drug product	2018-04-09
N208010-001	9925147	2028-04-25	U-2258	Drug product	2018-04-09
N208010-001	9925147	2028-04-25	U-2259	Drug product	2018-04-09
N208010-001	8361488	2028-07-19		Drug product	2016-07-06
N208010-001	8426391	2028-08-27	U-1872		2016-07-06
N208010-001	11801253	2030-09-07	U-3721	Drug product	2023-11-02
N208010-001	11801253	2030-09-07	U-3722	Drug product	2023-11-02
N208010-001	11801253	2030-09-07	U-3723	Drug product	2023-11-02
N208010-001	10300078	2034-03-14		Drug product	2019-06-18
N208010-001	10357502	2034-03-14		Drug product	2019-08-09
N208010-001	11253528	2034-03-14		Drug product	2022-03-04
N208010-001	9861644	2034-03-14		Drug product	2018-01-23

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208010-001	RAYALDEE	0.03MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208010-001	RAYALDEE	0.03MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208010-001	RAYALDEE	0.03MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208010-001	RAYALDEE	0.03MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 889 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208010-001	10213442	2027-02-02		Drug product	2019-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	8906410	2027-02-02		Drug product	2016-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9943530	2027-02-02	U-2274		2018-05-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	11154509	2028-04-25	U-3815		2021-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	8207149	2028-04-25	U-1871		2016-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	8778373	2028-04-25	U-1873		2016-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9408858	2028-04-25	U-1888		2016-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9498486	2028-04-25	U-3814		2016-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9925147	2028-04-25	U-2258	Drug product	2018-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9925147	2028-04-25	U-2255	Drug product	2018-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9925147	2028-04-25	U-2256	Drug product	2018-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9925147	2028-04-25	U-2257	Drug product	2018-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9925147	2028-04-25	U-2259	Drug product	2018-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	8361488	2028-07-19		Drug product	2016-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	8426391	2028-08-27	U-1872		2016-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	11801253	2030-09-07	U-3721	Drug product	2023-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	11801253	2030-09-07	U-3722	Drug product	2023-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	11801253	2030-09-07	U-3723	Drug product	2023-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	10300078	2034-03-14		Drug product	2019-06-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	10357502	2034-03-14		Drug product	2019-08-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	11253528	2034-03-14		Drug product	2022-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208010-001	9861644	2034-03-14		Drug product	2018-01-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208010-001	10213442	2027-02-02		Drug product	2019-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	8906410	2027-02-02		Drug product	2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9943530	2027-02-02	U-2274		2018-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	11154509	2028-04-25	U-3815		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	8207149	2028-04-25	U-1871		2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	8778373	2028-04-25	U-1873		2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9408858	2028-04-25	U-1888		2016-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9498486	2028-04-25	U-3814		2016-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9925147	2028-04-25	U-2258	Drug product	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9925147	2028-04-25	U-2255	Drug product	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9925147	2028-04-25	U-2256	Drug product	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9925147	2028-04-25	U-2257	Drug product	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	9925147	2028-04-25	U-2259	Drug product	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	8361488	2028-07-19		Drug product	2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	8426391	2028-08-27	U-1872		2016-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	11801253	2030-09-07	U-3721	Drug product	2023-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	11801253	2030-09-07	U-3722	Drug product	2023-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208010-001	11801253	2030-09-07	U-3723	Drug product	2023-11-02	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208010-001	NP	2019-06-17	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208010-001	NP	2019-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208010-001	NP	2019-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208010-001	NP	2019-06-17	`ea99ee380514…`

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
Rayaldee	CALCIFEDIOL	OPKO Pharmaceuticals LLC	6a95effd-32a5-46b6-a30e-7f4f9bf8cc77	2024-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208010 application number: NDA208010 ndc (product): 70301-1001

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70301-1001	Rayaldee	calcifediol	OPKO Pharmaceuticals LLC	NDA	Current
70301-1001	Rayaldee	calcifediol	OPKO Pharmaceuticals LLC	NDA	Current
70301-1001	Rayaldee	calcifediol	OPKO Pharmaceuticals LLC	NDA	Current
70301-1001	Rayaldee	calcifediol	OPKO Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77597	SUPPL	2024-02-22
77594	SUPPL	2024-02-22
61360	SUPPL	2019-12-20
61331	SUPPL	2019-12-18
46661	ORIG	2017-01-03
46660	ORIG	2017-01-03
40610	ORIG	2016-06-21
32876	ORIG	2016-06-21