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 2 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	St. Mary's Medical Park Pharmacy	2ad04535-1c34-6c5c-e063-6294a90a0c17	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	53e8777d-d54f-a9da-e063-6294a90a1608	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5370e633-53a3-3764-e063-6394a90a3cad	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Par Health USA, LLC	bb099db9-f635-4a64-8892-6236971dec45	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Cardinal Health 107, LLC	63b207da-159c-4cb5-8b06-616ed4811c12	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	400ac94f-2cf6-bd52-e063-6294a90a4f05	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	508a7d45-4efd-8532-e063-6294a90a7741	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	5025a55d-ff55-c810-e063-6294a90adfb3	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	05552560-6986-f9e8-e063-6394a90a4af0	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	21ec88b3-22c7-492b-bfb1-73d3f9852522	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	5734fac5-893d-4afd-95a1-e7ab4fd1df3a	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6fb9d156-f321-4f7d-b308-2a0e6056fd71	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	66cf2cc1-6011-4879-8b25-8701b0677ac6	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	4dddbff3-2531-b35e-e063-6294a90a1d3b	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	e20a1ccf-2f3a-4872-811e-d93fb56b8e83	2026-03-04	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	3c1e31d4-c8b5-459e-9ada-2f1bae7fa219	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Advagen Pharma Ltd.,	b4331e24-58af-45fb-a25b-9eb8270f83f7	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	ceba627b-5fe2-4ab3-b3bc-d90c3a170a93	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	380270a8-d0a6-44cb-bb34-f91db6e6ac71	2026-01-27	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