Application 019892

Type: NDA
Sponsor: RHODES PHARMS

Application Products#

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

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

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	TE codes	RLD / RS	Approval date
N019892-001	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07
N019892-002	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	RLD	2007-11-09
N019892-003	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	RLD	2007-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019892-001	AB
N019892-002	AB
N019892-003	AB

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 · 123 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
2026-02-19 14:30 UTC	2026-02	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019892-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019892-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019892-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019892-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	2427814c-f32b-8ac5-99b8-5e886fd2d001	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892 ndc (product): 63629-4284
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	53ddcacc-99e4-8b21-e063-6394a90a3e79	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	d6b40e39-a57e-402c-b4f6-7041e832f837	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892 ndc (product): 42858-338 ndc (product): 42858-234 ndc (product): 42858-122
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	37565441-0d95-4743-a695-d7b3326f58a1	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892 ndc (product): 42858-301 ndc (product): 42858-302 ndc (product): 42858-303
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	ASCLEMED USA INC.	18f6f54e-1537-4181-9d07-54ddf881a9ee	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-122	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-122	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-122	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-122	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-234	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-234	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-234	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-234	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-301	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-301	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-301	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-301	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-302	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-302	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-302	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-302	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-303	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-303	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-303	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-303	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-338	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-338	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-338	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-338	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
55154-1610	Dilaudid	hydromorphone hydrochloride	Cardinal Health	NDA	Current
59011-452	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
59011-454	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
59011-458	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
63629-3798	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3798	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-4284	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-4284	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-4284	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-4284	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
65084-440	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Mckesson Rxpak Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84683	SUPPL	2026-01-06
84591	SUPPL	2025-12-29
80090	SUPPL	2024-11-04
76995	SUPPL	2023-12-19
76896	SUPPL	2023-12-18
76895	SUPPL	2023-12-18
76228	ORIG	2023-11-03
66518	SUPPL	2021-03-05
66517	SUPPL	2021-03-05
66508	SUPPL	2021-03-05
60355	SUPPL	2019-10-08
60316	SUPPL	2019-10-08
60313	SUPPL	2019-10-08
55659	SUPPL	2018-09-28
55658	SUPPL	2018-09-28
55605	SUPPL	2018-09-24
55604	SUPPL	2018-09-24
46393	SUPPL	2016-12-21
46240	SUPPL	2016-12-20
11822	SUPPL	2007-11-19
1780	SUPPL	2007-11-19
19799	SUPPL	2006-06-12
11821	SUPPL	2006-06-12
1779	SUPPL	2004-06-02