Application 020658

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.25MG BASE	Yes	Yes
002	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.5MG BASE	Yes	No
003	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	Yes	No
004	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	Yes	No
005	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No
006	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	Yes	No
007	REQUIP	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020658-001	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19
N020658-002	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19
N020658-003	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19
N020658-004	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19
N020658-005	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19
N020658-006	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27
N020658-007	REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27

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 1 of 8 · 287 observed 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	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-006	REQUIP	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020658-007	REQUIP	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-006	REQUIP	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020658-007	REQUIP	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-006	REQUIP	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020658-007	REQUIP	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-006	REQUIP	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020658-007	REQUIP	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-006	REQUIP	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020658-007	REQUIP	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020658-001	REQUIP	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020658-002	REQUIP	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020658-003	REQUIP	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020658-004	REQUIP	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020658-005	REQUIP	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-09-19	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020658-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020658-007	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020658-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020658-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020658-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020658-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020658-007	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020658-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020658-007	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020658-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020658-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020658-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020658-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020658-005	AB	1	`3f01610625f2…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	a97d5e2d-4a17-4d80-9216-1b0780199502	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Northwind Health Company, LLC	ab6d21b6-2584-4b97-e053-2a95a90adc50	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	5823b3a2-3256-4d94-97b4-ec6b940312f4	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	3b8bb729-e084-4d45-9774-63cae192be32	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	AvKARE	abd344d9-7635-62a2-d4e1-38fc46937397	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	48a63d7e-c0af-4b09-863c-2af7beb2e80f	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	00c0ab77-914a-4e8a-bcb7-24cecacfebb1	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	9c4dacc6-cebc-4f42-85fc-41083512b290	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0007-4890	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4891	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4892	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4893	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4894	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4895	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
0007-4896	REQUIP	ropinirole	GlaxoSmithKline LLC	NDA	Current
63629-3760	REQUIP	ropinirole	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68095	SUPPL	2021-07-15
68072	SUPPL	2021-07-14
62513	SUPPL	2020-04-09
62452	SUPPL	2020-04-06
48332	SUPPL	2017-05-09
48315	SUPPL	2017-05-09
46965	SUPPL	2017-01-24
45293	SUPPL	2016-09-15
41527	SUPPL	2016-02-03
35091	SUPPL	2014-09-02
35090	SUPPL	2014-09-02
35089	SUPPL	2014-09-02
35088	SUPPL	2014-09-02
25455	SUPPL	2014-09-02
12936	SUPPL	2014-09-02
3016	SUPPL	2014-09-02
3015	SUPPL	2014-09-02
3014	SUPPL	2014-09-02
3013	SUPPL	2014-09-02
25456	SUPPL	2012-03-23
44064	ORIG	2011-12-20
35087	SUPPL	2009-01-06
35086	SUPPL	2009-01-06
25454	SUPPL	2009-01-06
25453	SUPPL	2009-01-06
12935	SUPPL	2009-01-06
3012	SUPPL	2009-01-06
41526	ORIG	2007-07-17
20806	SUPPL	2006-05-16
25452	SUPPL	2005-05-17
12934	SUPPL	2005-05-17
3011	SUPPL	2003-06-22