Application 202245

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CODEINE SULFATE	CODEINE SULFATE	SOLUTION;ORAL	30MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N202245-001	CODEINE SULFATE	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL			2011-06-30

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202245-001	CODEINE SULFATE	30MG/5ML	SOLUTION / ORAL	2011-06-30	`f41ea6bd6efb…`

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
Codeine Sulfate	CODEINE SULFATE	Lannett Company, Inc.	5819bdf7-300e-45b8-8f3a-447b53656293	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Codeine Sulfate generic name: CODEINE SULFATE
Codeine sulfate	CODEINE SULFATE	Hikma Pharmaceuticals USA Inc.	010905f9-3bcb-4b50-9fe8-a3ad0010f14c	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Codeine sulfate generic name: CODEINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84677	SUPPL	2026-01-06
84573	SUPPL	2025-12-29
80093	SUPPL	2024-11-04
77074	SUPPL	2023-12-19
77010	SUPPL	2023-12-19
76956	SUPPL	2023-12-18
76245	ORIG	2023-11-03
66639	SUPPL	2021-03-08
66638	SUPPL	2021-03-08
66576	SUPPL	2021-03-08
60412	SUPPL	2019-10-09
60411	SUPPL	2019-10-09
60376	SUPPL	2019-10-08
55720	SUPPL	2018-10-01
55719	SUPPL	2018-10-01
55572	SUPPL	2018-09-24
55571	SUPPL	2018-09-24
55570	SUPPL	2018-09-24
55569	SUPPL	2018-09-24
49634	SUPPL	2017-08-31
49616	SUPPL	2017-08-30
49615	SUPPL	2017-08-30
46427	SUPPL	2016-12-21
46304	SUPPL	2016-12-20
40143	SUPPL	2013-05-14
32215	SUPPL	2013-05-13
19301	SUPPL	2012-04-20
32214	SUPPL	2012-04-19
24411	ORIG	2012-02-13
22880	ORIG	2012-02-13
19300	ORIG	2011-07-06
9996	ORIG	2011-07-06