Application 077311

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	2MG	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	4MG	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	8MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077311-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09
A077311-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09
A077311-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077311-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077311-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077311-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2005-11-09	`1e350fbaab3a…`

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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	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	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
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
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	9eebd88a-5632-460f-b7b6-26c8a180540d	2025-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROMORPHONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23866	ORIG	2005-11-21