Application 079059

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	SOLUTION;ORAL	1MG/ML	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
A079059-001	RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2012-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079059-001	AA

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	A079059-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2012-12-12	`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	A079059-001	AA	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
Risperidone	RISPERIDONE	ATLANTIC BIOLOGICALS CORP.	dc8c6638-f487-49df-a265-78caa93e43d8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	REMEDYREPACK INC.	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	Bryant Ranch Prepack	4604052d-dbda-4535-b7b8-1bd72a129aca	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059
Risperidone	RISPERIDONE	Cranbury Pharmaceuticals, LLC	a0a21bec-68f0-444e-a611-d0602859410c	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059 ndc (product): 27808-002
Risperidone	RISPERIDONE	Bryant Ranch Prepack	3cc027f0-3462-4a2f-925b-d8a529bcb3c3	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079059 application number: ANDA079059

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
27808-002	Risperidone	Risperidone	Tris Pharma Inc	ANDA	Current
27808-002	Risperidone	Risperidone	Tris Pharma Inc	ANDA	Current
27808-002	Risperidone	Risperidone	Tris Pharma Inc	ANDA	Current
51991-716	Risperidone	Risperidone	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-716	Risperidone	Risperidone	Breckenridge Pharmaceutical, Inc.	ANDA	Current