Application 021217

Type: NDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXALGO	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	8MG	Yes	No
002	EXALGO	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12MG	Yes	No
003	EXALGO	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	16MG	Yes	No
004	EXALGO	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	32MG	Yes	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	RLD / RS	Approval date
N021217-001	EXALGO	HYDROMORPHONE HYDROCHLORIDE	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01
N021217-002	EXALGO	HYDROMORPHONE HYDROCHLORIDE	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01
N021217-003	EXALGO	HYDROMORPHONE HYDROCHLORIDE	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01
N021217-004	EXALGO	HYDROMORPHONE HYDROCHLORIDE	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021217-001	EXALGO	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021217-002	EXALGO	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021217-003	EXALGO	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021217-004	EXALGO	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-08-24	`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 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 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 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 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 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 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 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 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 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 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 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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	SpecGx LLC	NDA AUTHORIZED GENERIC	Current
23635-408	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-408	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-408	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-408	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-412	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-412	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-412	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-412	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-416	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-416	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-416	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-416	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-432	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-432	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-432	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current
23635-432	EXALGO	Hydromorphone Hydrochloride	SpecGx LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60346	SUPPL	2019-10-08
60335	SUPPL	2019-10-08
60334	SUPPL	2019-10-08
55979	SUPPL	2018-10-17
55978	SUPPL	2018-10-17
55675	SUPPL	2018-10-01
55674	SUPPL	2018-10-01
48566	SUPPL	2017-05-30
46357	SUPPL	2016-12-21
46278	SUPPL	2016-12-20
45463	SUPPL	2016-10-04
27089	SUPPL	2016-04-22
4657	SUPPL	2015-07-02
14646	SUPPL	2015-06-04
4655	SUPPL	2015-06-04
4656	SUPPL	2014-08-20
14647	SUPPL	2014-06-26
27087	SUPPL	2014-06-19
27088	SUPPL	2014-04-17
36371	SUPPL	2014-04-16
4654	SUPPL	2013-04-17
4653	SUPPL	2013-03-19
36370	SUPPL	2013-03-18
27086	SUPPL	2012-08-28
14645	SUPPL	2012-08-28
36369	SUPPL	2012-07-12
44474	ORIG	2012-07-11
4652	SUPPL	2012-07-11
42033	ORIG	2010-05-23
24188	ORIG	2010-05-23
27085	SUPPL	2010-03-31
4651	ORIG	2010-03-03
36368	ORIG	2010-03-02