Application 070765

Type: ANDA
Sponsor: FRONTIDA BIOPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	TABLET;ORAL	EQ 12.5MG BASE;5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A070765-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A070765-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070765-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070765-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	1986-12-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070765-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	1986-12-10	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide and Amitriptyline Hydrochloride	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	66a756f2-ac77-451c-a19a-08896d73b15c	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide and Amitriptyline Hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53944	ORIG	2018-05-01