Application 076373

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL	CARVEDILOL	TABLET;ORAL	3.125MG	No	No
002	CARVEDILOL	CARVEDILOL	TABLET;ORAL	6.25MG	No	No
003	CARVEDILOL	CARVEDILOL	TABLET;ORAL	12.5MG	No	No
004	CARVEDILOL	CARVEDILOL	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076373-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A076373-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A076373-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A076373-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076373-001	AB
A076373-002	AB
A076373-003	AB
A076373-004	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`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	A076373-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-004	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	A-S Medication Solutions	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	QPharma, Inc.	ffbedcce-0d64-4aed-9e65-09448d71ca91	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373 ndc (product): 42708-072
Carvedilol	CARVEDILOL	Proficient Rx LP	52785a22-ddca-4f5b-8579-5974df2a9a4e	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	NCS HealthCare of KY, LLC dba Vangard Labs	2fb46fe1-9b7b-4718-9327-2471af22f0b7	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373 ndc (product): 0615-8388 ndc (product): 0615-8387 ndc (product): 0615-8389 ndc (product): 0615-8390
Carvedilol	CARVEDILOL	Proficient Rx LP	da2696ba-f4be-4626-9abe-fe33f36361b1	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Teva Pharmaceuticals USA, Inc.	68c275e8-992a-4520-8065-ab6d615d89cc	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373 ndc (product): 0093-7295 ndc (product): 0093-7296 ndc (product): 0093-0135 ndc (product): 0093-0051

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0051	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0051	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0051	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0135	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0135	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0135	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7295	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7295	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7295	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7296	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7296	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7296	Carvedilol	Carvedilol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-8387	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8387	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8388	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8388	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8389	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8389	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8390	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8390	Carvedilol	Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
42708-072	Carvedilol	Carvedilol	QPharma Inc	ANDA	Current
42708-072	Carvedilol	Carvedilol	QPharma Inc	ANDA	Current
42708-072	Carvedilol	Carvedilol	QPharma Inc	ANDA	Current
50090-5115	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-5115	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
66116-361	Carvedilol	Carvedilol	MedVantx, Inc.	ANDA	Current
66116-429	Carvedilol	Carvedilol	MedVantx, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8902	ORIG	2007-09-07