Application 021264

Type: NDA
Sponsor: US WORLDMEDS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APOKYN	APOMORPHINE HYDROCHLORIDE	INJECTABLE;SUBCUTANEOUS	20MG/2ML (10MG/ML)	No	No
002	APOKYN	APOMORPHINE HYDROCHLORIDE	INJECTABLE;SUBCUTANEOUS	30MG/3ML (10MG/ML)	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021264-001	APOKYN	APOMORPHINE HYDROCHLORIDE	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20
N021264-002	APOKYN	APOMORPHINE HYDROCHLORIDE	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021264-002	AP

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021264-001	APOKYN	20MG/2ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS			2004-04-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021264-002	APOKYN	30MG/3ML (10MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-04-20	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021264-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021264-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021264-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021264-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021264-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021264-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021264-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021264-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021264-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021264-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021264-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021264-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021264-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021264-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021264-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021264-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021264-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021264-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021264-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021264-002	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021264-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021264-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021264-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021264-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021264-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021264-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021264-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021264-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021264-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021264-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021264-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021264-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021264-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021264-002	AP	1	`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
apomorphine hydrocloride	APOMORPHINE HYDROCHLORIDE	TruPharma, LLC	aedf70e4-1949-44bc-bf1b-0f282c4f0705	2022-02-24	Warnings, Adverse reactions	Name fallback generic name: APOMORPHINE HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	US WorldMeds, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	US WorldMeds, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	US WorldMeds, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	US WorldMeds, LLC	NDA	Current
27505-004	APOKYN	APOMORPHINE HYDROCHLORIDE	US WorldMeds, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81127	SUPPL	2025-02-07
81059	SUPPL	2025-02-06
71448	SUPPL	2022-06-24
71431	SUPPL	2022-06-23
71023	SUPPL	2022-05-06
71008	SUPPL	2022-05-06
62818	SUPPL	2020-05-05
62810	SUPPL	2020-05-04
61969	SUPPL	2020-02-26
61141	SUPPL	2019-12-04
58825	SUPPL	2019-05-22
58803	SUPPL	2019-05-21
47589	SUPPL	2017-03-20
47582	SUPPL	2017-03-17
14781	SUPPL	2014-07-28
4824	SUPPL	2014-07-28
36503	SUPPL	2010-09-07
27263	SUPPL	2010-09-07
27262	SUPPL	2009-01-06
27261	SUPPL	2009-01-06
21554	ORIG	2004-08-27
36502	ORIG	2004-05-04
27260	ORIG	2004-04-29