Application 091591

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	CAPSULE;ORAL	30MG	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
A091591-001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB		2013-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091591-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091591-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091591-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091591-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091591-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091591-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091591-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091591-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091591-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091591-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091591-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091591-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091591-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091591-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091591-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091591-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091591-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091591-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091591-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091591-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091591-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091591-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091591-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091591-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091591-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091591-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091591-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091591-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091591-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091591-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091591-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091591-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091591-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091591-001	AB	1	`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
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	fe30c870-a060-4a5b-ae61-6a9933854419	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091591 application number: ANDA091591
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1167360c-7e0f-4619-9d1a-ad4ee56cab71	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091591 application number: ANDA091591 ndc (product): 0054-0334

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0334	Cevimeline Hydrochloride	Cevimeline Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0334	Cevimeline Hydrochloride	Cevimeline Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0334	Cevimeline Hydrochloride	Cevimeline Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current