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	TE codes	RLD / RS	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	Product TE source text	RLD / RS	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 1 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	Redpharm Drug	59d88866-e1ba-9d97-e063-6394a90a7b27	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	67e79859-4efc-4ea7-8211-cadf746bc864	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	31d5a37a-0e90-4e88-be14-75c877be9de2	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	9eebd88a-5632-460f-b7b6-26c8a180540d	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	e034eb96-03e0-46e1-8b92-5e1f94555e7b	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	SpecGx LLC	4c5c1cc8-c42b-46e3-ad68-8e22f57101f2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	2427814c-f32b-8ac5-99b8-5e886fd2d001	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	53ddcacc-99e4-8b21-e063-6394a90a3e79	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	d6b40e39-a57e-402c-b4f6-7041e832f837	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Teva Parenteral Medicines, Inc.	f0b78db9-a38c-41bb-8233-5e93f7f18c5c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	37565441-0d95-4743-a695-d7b3326f58a1	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	American Health Packaging	fab97112-e276-40e0-bc82-0a29d7fa75fa	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	3832ede8-d3fc-455d-ecab-3b77be5869f5	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b325028e-0722-4c8c-9fdb-ab6fb0dc460c	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	American Health Packaging	e4758743-9b2c-4612-8399-ad2db372e2b7	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	cc574063-6ede-4da7-82c4-7450c92b229b	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c729424e-e483-4bf8-b86c-ce56636dcffa	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydromorphone Hydrochloride generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	2025-12-31	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