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 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	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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205814-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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