Application 210788

Type: ANDA
Sponsor: CUSTOPHARM INC

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
A210788-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2019-02-11

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	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210788-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-02-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210788-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210788-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210788-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210788-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210788-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210788-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210788-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210788-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210788-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210788-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210788-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210788-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210788-001	AP	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A210788-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210788-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210788-001	AP	1	`cb3db0bc1861…`

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 4 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	A-S Medication Solutions	3713ae82-f36d-4491-9978-3111599ceafb	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	acb5ab87-2eb4-4fc9-b7f1-cc8cb71bd73b	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	1f3f4e0e-c04d-4208-8549-2bacaf547176	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Trifluent Pharma, LLC	56282794-5874-4220-b25c-cea4b17d19aa	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	8652905b-b3f1-4eed-bde8-ce507186ae9a	2025-08-12	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation	4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation	d46259e6-5eca-4356-bc18-815104c925cc	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	2025-06-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	2f89e438-6a8a-917e-e063-6294a90a1c23	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a5864c57-d73c-45c6-8985-7a041c84ccad	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2c656550-7e5b-445f-e063-6294a90a8f52	2025-02-24	Warnings, Adverse reactions	Name fallback generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	8561b68a-c88b-4047-9fcf-2df7344543b2	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	2d439669-5cbc-292f-e063-6394a90a7ca9	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	87cd2a04-54d6-4022-b365-646692a42f56	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	da0e1f63-cb90-4c2a-908f-7d81e672be10	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8c29140b-e181-4807-870f-28e315c6d4c4	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b3d591ad-4eb7-4cdf-93b2-62cd479e921b	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1cebadd3-2c45-9cff-e063-6394a90aaceb	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Somerset Therapeutics, LLC	7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	0590c805-537e-46d3-9500-f4942c1df2ea	2024-10-19	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24201-585	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride Injection	Leucadia Pharmaceuticals, Inc.	ANDA	Current
24201-585	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride Injection	Leucadia Pharmaceuticals, Inc.	ANDA	Current
24201-585	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride Injection	Leucadia Pharmaceuticals	ANDA	Current