Application 090132

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
003	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
004	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No

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

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	RLD / RS	Approval date
A090132-001	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25
A090132-002	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25
A090132-003	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25
A090132-004	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090132-001	AB
A090132-002	AB
A090132-003	AB
A090132-004	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.

Product history page 1 of 5 · 168 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
2026-08-18 06:07:40	2026-07	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090132-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090132-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090132-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-004	AB	1	`d8e5a09893c0…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	3697789e-ed17-4433-af94-e8ea19d8e04d	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	ce9623f8-6cea-45e0-a15c-2dd78690f2a7	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	NorthStar RxLLC	63065e30-4a50-42b0-9622-a393923c1e98	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132 ndc (product): 16714-230 ndc (product): 16714-229 ndc (product): 16714-228 ndc (product): 16714-227
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Golden State Medical Supply, Inc.	669ec7f8-f27d-4048-a784-00ca903cc658	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132 ndc (product): 51407-051 ndc (product): 51407-052 ndc (product): 51407-050 ndc (product): 51407-053
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Sun Pharmaceutical Industries, Inc.	a9314bc0-fd5d-477b-bef5-3bee532774c0	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132 ndc (product): 57664-665 ndc (product): 57664-666 ndc (product): 57664-664 ndc (product): 57664-663
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	c462ce0b-486d-4599-ba60-b836781779d3	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	cea10014-72b0-4190-a391-733c8912efe0	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Coupler LLC	325dae60-01ce-a120-e063-6294a90a2ef2	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-227	Carvedilol Phosphate	Carvedilol Phosphate	NorthStar RxLLC	ANDA	Current
16714-228	Carvedilol Phosphate	Carvedilol Phosphate	NorthStar RxLLC	ANDA	Current
16714-229	Carvedilol Phosphate	Carvedilol Phosphate	NorthStar RxLLC	ANDA	Current
16714-230	Carvedilol Phosphate	Carvedilol Phosphate	NorthStar RxLLC	ANDA	Current
51407-050	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply Inc.	ANDA	Current
51407-050	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-050	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-051	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply Inc.	ANDA	Current
51407-051	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-051	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-052	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply Inc.	ANDA	Current
51407-052	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-052	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-053	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply Inc.	ANDA	Current
51407-053	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
51407-053	Carvedilol Phosphate	Carvedilol Phosphate	Golden State Medical Supply, Inc.	ANDA	Current
57664-663	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-663	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-664	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-664	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-665	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-665	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-666	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-666	Carvedilol Phosphate	Carvedilol Phosphate	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50342	ORIG	2017-11-08