Application 022331

Type: NDA
Sponsor: CONCORDIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JENLOGA	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	JENLOGA	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	KAPVAY	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.1MG	Yes	Yes
004	KAPVAY	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022331-001	JENLOGA	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30
N022331-002	JENLOGA	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25
N022331-003	KAPVAY	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28
N022331-004	KAPVAY	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28

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 5 · 164 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	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-003	KAPVAY	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022331-001	JENLOGA	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022331-002	JENLOGA	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022331-003	KAPVAY	0.1MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022331-004	KAPVAY	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-09-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022331-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022331-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022331-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022331-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022331-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022331-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022331-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022331-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022331-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022331-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022331-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022331-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022331-003	AB1	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N022331-003	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022331-003	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022331-003	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022331-003	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022331-003	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022331-003	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022331-003	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022331-003	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022331-003	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022331-003	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022331-003	AB1	1	`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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e96ab74c-eedf-4d71-8a35-d5ec3daa7592	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	574640a5-829d-4e9d-be32-832a48cbd8dd	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	2a183d05-5be7-43e9-a084-700ec05d01e9	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	32d72d7b-5881-f431-e063-6394a90a3547	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	cee049ea-a476-433c-971f-2466a6a3263b	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	7ec53e25-c50a-48b4-82b0-c0b3626f31dc	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ea1527a5-4939-4ff7-a827-f88a9113a07d	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be1b921d-152e-4bd5-82bd-56e2f8beef3e	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	ASCLEMED USA INC.	200afa03-adf3-4dca-8de8-1569701bd029	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	666e757e-9b43-2e40-e053-2991aa0a59a2	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	50c8a725-a449-256b-e063-6294a90a3e44	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	32e740a9-51e1-4add-8f99-523fb9cb8b2e	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	b359baee-6faf-4f7d-be86-ba7a1b1de770	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-658	Kapvay	clonidine hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-776	Clonidine hydrochloride extended-release	clonidine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61848	SUPPL	2020-02-07
61838	SUPPL	2020-02-07
48433	SUPPL	2017-05-17
45195	SUPPL	2016-08-16
45130	SUPPL	2016-08-16
38587	SUPPL	2015-06-10
29606	SUPPL	2015-06-10
17250	SUPPL	2014-12-16
29605	SUPPL	2014-11-21
17249	SUPPL	2013-02-14
7246	SUPPL	2013-02-14
38586	SUPPL	2010-10-07
17248	SUPPL	2010-10-07
17247	SUPPL	2010-10-07
29604	SUPPL	2010-10-04
29603	SUPPL	2010-10-04
21995	ORIG	2009-11-10
38585	ORIG	2009-10-07
7245	ORIG	2009-10-07
66954	ORIG	1900-01-01
66953	ORIG	1900-01-01
66952	ORIG	1900-01-01
53219	ORIG	1900-01-01
53218	ORIG	1900-01-01
53216	ORIG	1900-01-01