Application 218310

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	TABLET;ORAL	20MG	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
A218310-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2025-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A218310-001	AB

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.

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	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218310-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-06-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218310-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218310-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218310-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218310-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218310-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218310-001	AB	1	`a50c72e98297…`

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 6 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	NuCare Pharmaceuticals,Inc.	0d07a460-5cb1-cd4b-e063-6294a90a291d	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c77ef2f7-a846-5e05-e053-2995a90aaae0	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	b3b8ee01-ec7c-4b17-a237-59ba45cdf3f9	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Solco Healthcare US,LLC	d0954a7a-812b-487e-8c22-2a2a58303277	2023-07-28	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	01413a77-48f8-1a8a-e063-6394a90ae494	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	346bbb6a-3499-4e90-af22-95f1cd0c0417	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99d7d1ce-47b5-4bbd-afe0-908505a9a51b	2023-06-05	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	ec746016-eed0-4e37-bb9c-cb430c8a7f07	2023-05-19	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	d81b93f8-bebc-455e-82b6-9a3de3f82e92	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	5f5d7145-118b-4cab-bfe0-19f7740ef1fe	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5a553bda-1e3d-4b80-913f-73dd54655033	2021-11-30	Warnings, Adverse reactions	Name fallback generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Novitium Pharma LLC	b0911994-0b36-439d-8247-5d885a899421	2021-04-23	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	American Regent, Inc.	cab4ecaf-8895-4ae8-add3-233d9cc570a8	2021-03-01	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Fosun Pharma USA Inc.	cbc22f25-e100-4c59-8f38-5f82113166fb	2019-10-19	Warnings, Adverse reactions	Name fallback brand name: DICYCLOMINE HYDROCHLORIDE generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	860e8ea6-6f9b-4fe6-a23d-3600b69c0b35	2019-04-29	Warnings, Adverse reactions	Name fallback brand name: Dicyclomine Hydrochloride generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	da2c43f8-1c3a-447f-8994-f9899fb5e141	2018-12-20	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.