Application 076156

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	SPRAY, METERED;NASAL	0.021MG/SPRAY	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
A076156-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB		2003-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076156-001	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	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB		2003-04-18	`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	A076156-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide	IPRATROPIUM BROMIDE	NORTHSTAR RX LLC	6493c00f-2306-2cb6-9624-4ea678f66576	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076156 application number: ANDA076156 ndc (product): 16714-526
Ipratropium Bromide	IPRATROPIUM BROMIDE	Apotex Corp.	ac641027-929e-694d-80cd-bf770dc51aa6	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076156 application number: ANDA076156 ndc (product): 60505-0826

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
16714-526	Ipratropium Bromide	Ipratropium Bromide	NORTHSTAR RX LLC	ANDA	Current
60505-0826	Ipratropium Bromide	Ipratropium Bromide	Apotex Corp.	ANDA	Current
60505-0826	Ipratropium Bromide	Ipratropium Bromide	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22540	ORIG	2005-07-22