Application 076697

Type: ANDA
Sponsor: NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No
002	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	No	No
003	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076697-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20
A076697-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20
A076697-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076697-001	AB
A076697-002	AB
A076697-003	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 4 · 129 observed 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
2026-09-14 22:38:34	2026-08	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076697-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076697-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076697-001	AB	1	`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	ANI Pharmaceuticals, Inc.	c1876184-0323-4b06-b459-603b40c0c002	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33ed4e35-8be2-d0ea-e063-6394a90a06a6	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33edb22f-f357-ec0f-e063-6394a90a7bc3	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	2d936849-9c80-5b7f-e063-6294a90aaa6c	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29033-004	Carbamazepine	carbamazepine	Nostrum Laboratories, Inc.	ANDA	Current
29033-004	Carbamazepine	Carbamazepine	Nostrum Laboratories, Inc.	ANDA	Current
29033-019	Carbamazepine	carbamazepine	Nostrum Laboratories, Inc.	ANDA	Current
29033-020	Carbamazepine	carbamazepine	Nostrum Laboratories, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22579	ORIG	2013-10-23
8950	ORIG	2011-05-24