Application 202144

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	8MG	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12MG	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	16MG	No	No
004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	32MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A202144-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`5bbf6a4d5a75…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Trigen Laboratories, LLC	8bb81796-6990-40e9-bee4-1f292f91ae99	2025-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Padagis US LLC	780a2616-0392-4715-bc50-71799bea1957	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: hydromorphone hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	ASCLEMED USA INC.	18f6f54e-1537-4181-9d07-54ddf881a9ee	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	c33e6320-4206-4b69-8cac-ebfc2351b8f2	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: hydromorphone hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Ascent Pharmaceuticals Inc	4de15afe-d676-4faa-a34d-9b9cb20dbf54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HYDROMORPHONE HYDROCHLORIDE generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	29765ff0-3b1d-47da-953e-28bf0e6a56ef	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HYDROMORPHONE HYDROCHLORIDE generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride	HYDROMORPHONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	90bda45c-9dbe-4ed5-91d0-df8446ad7026	2024-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: hydromorphone hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	bec32a94-4b79-4bd4-b000-45e9030d3106	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HYDROMORPHONE HYDROCHLORIDE generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	f778dfab-e109-428e-b1b7-4dfb1b8293e4	2023-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HYDROMORPHONE HYDROCHLORIDE generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Padagis US LLC	1bfbba46-1979-4797-a29e-d67718131686	2023-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HYDROMORPHONE HYDROCHLORIDE generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Ascent Pharmaceuticals Inc	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	2017-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3629	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3630	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3631	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Actavis Pharma, Inc.	ANDA	Current
0591-3739	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40132	SUPPL	2016-07-08
9972	SUPPL	2016-07-01
44580	ORIG	2015-06-30
40131	ORIG	2014-08-05
32192	ORIG	2014-05-13