Application 040648

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISONIAZID	ISONIAZID	INJECTABLE;INJECTION	100MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040648-001	ISONIAZID	ISONIAZID	100MG/ML	INJECTABLE / INJECTION		RS	2005-07-05

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 · 42 observed 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
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION		RS	2005-07-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION		RS	2005-07-05	`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
Isoniazid	ISONIAZID	Sandoz Inc	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040648 application number: ANDA040648 ndc (product): 0781-3056

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3056	Isoniazid	Isoniazid	Sandoz Inc	ANDA	Current
0781-3056	Isoniazid	Isoniazid	Sandoz Inc	ANDA	Current
0781-3056	Isoniazid	Isoniazid	Sandoz Inc	ANDA	Current
0781-3056	Isoniazid	Isoniazid	Sandoz Inc	ANDA	Current
0781-3056	Isoniazid	Isoniazid	Sandoz Inc	ANDA	Current