Application 208269

Type: ANDA
Sponsor: ALVOGEN PINE BROOK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	20MG	No	No
002	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No
003	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	40MG	No	No
004	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
005	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	80MG	No	No
006	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
007	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	120MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208269-001	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-002	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-003	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-004	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-005	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-006	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01
A208269-007	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A208269-001	AB
A208269-002	AB
A208269-003	AB
A208269-004	AB
A208269-005	AB
A208269-006	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 6 · 238 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	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-006	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-007	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-006	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-007	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-006	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-007	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-006	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-007	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-006	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-007	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		2021-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-001	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-002	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-003	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-004	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-005	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-03-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 231 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	A208269-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208269-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208269-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208269-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208269-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208269-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208269-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208269-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208269-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208269-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208269-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208269-004	AB	1	`2680178bc6a6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate	HYDROCODONE BITARTRATE	Alvogen Inc.	f7b55d14-0980-b680-8ceb-7489ff65455e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208269 application number: ANDA208269 ndc (product): 47781-393 ndc (product): 47781-396 ndc (product): 47781-392 ndc (product): 47781-394 ndc (product): 47781-398 ndc (product): 47781-397 ndc (product): 47781-395

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-392	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-392	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-392	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-393	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-393	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-393	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-394	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-394	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-394	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-395	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-395	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-395	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-396	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-396	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-396	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-397	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-397	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-397	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-398	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-398	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current
47781-398	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Alvogen Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76469	ORIG	2023-11-07
67033	ORIG	2021-04-13