Application 091260

Type: ANDA
Sponsor: APOTEX INC

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
A091260-001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2011-08-25

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	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091260-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	2011-08-25	`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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b429ea7-1c7c-47a4-803c-2546736f5c36	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: CEVIMELINE HYDROCHLORIDE generic name: CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	7fa69ad5-7fa7-4078-9328-aacbb0d145a4	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: cevimeline hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	ASCLEMED USA INC.	bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc4	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	75ae16d6-8822-4581-b747-ae894a45cdea	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: CEVIMELINE HYDROCHLORIDE generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Zydus Lifesciences Limited	1a29e9ab-edb0-4ae8-8f20-f43d122d2b43	2026-03-16		Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	990887c1-11ce-4a73-83b4-0ffc5a900c85	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	Advagen Pharma Ltd	61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: CEVIMELINE HYDROCHLORIDE generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	71ada1b0-3344-4202-9277-57f1a37402c1	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	ca0409bc-2685-4ffd-b806-04898902a597	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	fe30c870-a060-4a5b-ae61-6a9933854419	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	51307f82-66f2-41c7-80ff-174d7e50f7ee	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	d4bd942a-1339-40c5-8fd4-850da5a69635	2024-08-02	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
CEVIMELINE	CEVIMELINE HYDROCHLORIDE	Bionpharma Inc	0f15cb50-5917-c928-e063-6294a90ab284	2024-02-08	Warnings, Adverse reactions	Name fallback generic name: CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	0fbcf1a7-5b8b-42fb-b764-4b529e7d1a99	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: cevimeline hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1167360c-7e0f-4619-9d1a-ad4ee56cab71	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Aurobindo Pharma Limited	d08d8aa5-76a4-417a-a308-7d195865522f	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Cevimeline Hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	efc2bb24-4dda-4781-bef5-fcd9abf082dd	2023-01-05	Warnings, Adverse reactions	Name fallback brand name: cevimeline hydrochloride generic name: CEVIMELINE HYDROCHLORIDE
Evoxac	CEVIMELINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	dac32a9b-05b8-42c2-9a29-d885a9279456	2022-09-07	Warnings, Adverse reactions	Name fallback generic name: CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Novel Laboratories, Inc.	d7432a48-1142-431e-997f-8419dc724824	2016-02-09	Warnings, Adverse reactions	Name fallback brand name: cevimeline hydrochloride generic name: CEVIMELINE HYDROCHLORIDE

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
9327	ORIG	2011-08-26