Application 217916

Type: ANDA
Sponsor: BIONPHARMA

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 1.

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
A217916-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2023-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217916-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2023-08-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A217916-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	4dddbff3-2531-b35e-e063-6294a90a1d3b	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3ee013cc-ab23-40a1-a44d-1d027c63b132	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	8561b68a-c88b-4047-9fcf-2df7344543b2	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bionpharma Inc.	051bfee3-06cf-309a-e063-6394a90a0bb3	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916