Application 212058

Type: ANDA
Sponsor: SUNGEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	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
A212058-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2019-04-26

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	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212058-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-04-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A212058-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212058-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212058-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212058-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212058-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212058-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212058-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212058-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212058-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212058-001	AP	1	`ea99ee380514…`

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 5 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Chartwell RX, LLC	d628ac1c-404d-45eb-8aab-0e550c95ed4a	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	82832a91-d16c-3a63-e053-2a91aa0a3ffb	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	20ef2c05-d0a4-405c-e063-6394a90ae697	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	American Health Packaging	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	07361f0e-90c7-4531-8d3f-1ec5e7fed40d	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	a16e7b6b-dbc9-463d-9bde-dba4f25589cf	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	40e21575-320f-2ac6-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e2022	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	600f3b80-0303-4f2d-929b-edb689b5b357	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e0260d0-aaad-aa9f-e063-6294a90a531a	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	350ce812-b9a7-401a-9793-55d2e14bb760	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7c75f650-c97d-06fa-e053-2991aa0a43bb	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	51742add-363d-3f9d-e054-00144ff8d46c	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	517646d8-366e-5cf2-e054-00144ff88e88	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b420733-b3b7-e504-e063-6394a90abba7	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bionpharma Inc.	051bfee3-06cf-309a-e063-6394a90a0bb3	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	26a94263-46c0-4938-849c-ffb396e48dd3	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5937c7b-cdfc-46e6-a0fa-541b24f91d47	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	b3c9dc85-2c6c-44f0-9c98-02673af934cb	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	226a3a6e-9419-448a-827f-01199b792762	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-963	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-963	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
70625-103	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	SunGen Pharma LLC	ANDA	Current
70625-103	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	Praxgen Pharmaceuticals LLC	ANDA	Current