Application 214044

Type: NDA
Sponsor: ATHENA BIOSCIENCE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QDOLO	TRAMADOL HYDROCHLORIDE	SOLUTION;ORAL	5MG/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214044-001	QDOLO	TRAMADOL HYDROCHLORIDE	5MG/ML	SOLUTION / ORAL		RLD	2020-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02
N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD, RS	2020-09-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214044-001	QDOLO	5MG/ML	SOLUTION / ORAL	RLD	2020-09-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214044-001	11752103	2040-09-01	U-3197	Drug product	2023-09-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214044-001	11103452	2040-09-01	U-3197	Drug product	2021-09-02	`a72a2bbeb626…`

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
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TruPharma, LLC	aea56ff9-94ac-47a8-8f15-8790d538973b	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214044 application number: NDA214044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68134-402	tramadol hydrochloride	tramadol hydrochloride	Palmetto Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
71511-301	QDOLO	tramadol hydrochloride	Athena Bioscience, LLC	NDA	Current
71511-301	QDOLO	tramadol hydrochloride	Athena Bioscience, LLC	NDA	Current
71511-301	QDOLO	tramadol hydrochloride	Athena Bioscience, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84632	SUPPL	2026-01-05
84586	SUPPL	2025-12-29
80087	SUPPL	2024-11-04
77062	SUPPL	2023-12-19
76978	SUPPL	2023-12-19
76977	SUPPL	2023-12-19
76465	ORIG	2023-11-07
68618	SUPPL	2021-09-14
68602	SUPPL	2021-09-13
68080	ORIG	2021-07-14
66892	ORIG	2021-03-26
66891	ORIG	2021-03-26
66893	ORIG	2020-09-02
64484	SUPPL	2020-09-02