Application 205814

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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	TE codes	Approval date
A205814-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13
A205814-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13
A205814-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205814-001	AB
A205814-002	AB
A205814-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205814-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205814-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205814-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205814-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205814-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205814-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-001	AB	1	`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 1 · 2 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	29765ff0-3b1d-47da-953e-28bf0e6a56ef	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205814 application number: ANDA205814 ndc (product): 71335-0723
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	f778dfab-e109-428e-b1b7-4dfb1b8293e4	2023-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205814 application number: ANDA205814 ndc (product): 13107-107 ndc (product): 13107-109 ndc (product): 13107-108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-107	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
13107-107	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
13107-108	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
13107-108	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
13107-109	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
13107-109	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	ANDA	Current
71335-0723	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0723	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0723	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0887	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0887	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76051	ORIG	2023-11-02