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 3 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	Rising Pharma Holdings, Inc.	0a97e9c8-7046-4b92-93ad-dd9e01ce0fc4	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	029baf6d-4e85-48fd-9efc-158fe0f629bb	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3ee013cc-ab23-40a1-a44d-1d027c63b132	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	59422db6-b22d-447a-9393-46347406b338	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	4f6f4402-865b-44fb-9bfe-4e224d57e6dc	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	dd3a8428-f71f-4f39-91c9-328d2a30eeba	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	da82cb46-7b4b-1ef5-e053-2a95a90ad10d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	d9bb7ff1-8dbc-d191-e053-2995a90a13db	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	c195b8ea-c1bf-453f-e053-2a95a90a2121	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	1d9acff5-6e8c-58dd-e063-6394a90a38f2	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	1aebc66d-0636-45ef-8110-7ff49d4dced5	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3b0ae3ed-77ef-d0df-e063-6294a90a7d17	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3252540c-980d-40ca-e063-6394a90ad1c9	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3745661f-5d24-487d-e063-6294a90a5a68	2025-12-13	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	QPharma, Inc.	f5dd6ecc-440d-6c47-e053-2a95a90a92d3	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3de47f8d-e265-3f40-e063-6394a90aa3b0	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43e30378-6376-caab-e063-6294a90a8696	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	dda92fd9-d0e2-447b-aae6-012f089a4c2f	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	c60cb7fd-0ec7-4b6c-a535-34d79b2167b6	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3c6dec02-b146-dd36-e063-6294a90ad7d2	2025-11-03	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