Application 022331
- Type
- NDA
- Sponsor
- CONCORDIA PHARMS INC
Application Products#
| 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| TABLET, EXTENDED RELEASE;ORAL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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| JENLOGA | CLONIDINE HYDROCHLORIDE | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-09-30 | |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| JENLOGA | CLONIDINE HYDROCHLORIDE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-05-25 | |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| KAPVAY | CLONIDINE HYDROCHLORIDE | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-09-28 | |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| KAPVAY | CLONIDINE HYDROCHLORIDE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-09-28 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Cardinal Health 107, LLC | 32e740a9-51e1-4add-8f99-523fb9cb8b2e | 2026-04-21 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | b359baee-6faf-4f7d-be86-ba7a1b1de770 | 2026-04-20 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 0906c25f-e5b8-4a08-9b10-d1f06419e275 | 2026-04-20 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | c8e151d6-50c6-47a1-80b0-bd8e07acddd2 | 2026-04-20 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | REMEDYREPACK INC. | e413efdf-980b-4b33-80f1-5be899a10f01 | 2026-04-08 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6 | 2026-03-31 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 55ab721b-7b4c-42d5-99e3-745008fe139c | 2026-03-31 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 56a80e79-9cfe-4361-a90a-9245632efa05 | 2026-03-31 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 770b56aa-fcf3-4327-98d1-d87e5a037234 | 2026-03-31 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 21bfa28f-20df-43fd-bb80-b720d3b40696 | 2026-03-30 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7484e8fa-13a7-70e9-e053-2a91aa0a24b7 | 2026-03-02 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | a32f4b18-1090-4d79-a56b-39c0cf366bbc | 2026-02-05 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1ab3b82f-db7f-22bf-e063-6294a90ae93f | 2026-01-13 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | ab2ffb6e-7070-063b-e053-2a95a90aff22 | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | 66dc3cf0-d6bd-436c-9a7f-7477575b3260 | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | df603f27-d341-3957-e053-2995a90a825f | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | f30324be-47b6-7f54-e053-2995a90a3ad4 | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | df77e732-9765-ee5c-e053-2a95a90abc92 | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | 18c873b1-f2fe-4ba9-b384-38e917af373b | 2026-01-01 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | BluePoint Laboratories | 1ea412db-d847-4094-be83-e3bd7328537a | 2025-11-04 | Warnings, Adverse reactions | CLONIDINE HYDROCHLORIDE |
NDC Listings For This Application#
| 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 |
|---|---|---|
| 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 |