Application 020712

Type: NDA
Sponsor: SHIRE DEV LLC

Application Products#

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

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

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	RLD / RS	Approval date
N020712-001	CARBATROL	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30
N020712-002	CARBATROL	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30
N020712-003	CARBATROL	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020712-001	AB
N020712-002	AB
N020712-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbatrol	CARBAMAZEPINE	Takeda Pharmaceuticals America, Inc.	bc03e499-5bac-4293-bff4-6864153a624d	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020712 application number: NDA020712 ndc (product): 54092-171 ndc (product): 54092-173 ndc (product): 54092-172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0407	Carbamazepine	carbamazepine	ATLANTIC BIOLOGICALS CORP.	NDA AUTHORIZED GENERIC	Current
17856-0407	Carbamazepine	carbamazepine	ATLANTIC BIOLOGICALS CORP.	NDA AUTHORIZED GENERIC	Current
54092-171	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-171	Carbatrol	carbamazepine	Shire US Manufacturing Inc.	NDA	Current
54092-171	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-171	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-171	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-172	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-172	Carbatrol	carbamazepine	Shire US Manufacturing Inc.	NDA	Current
54092-172	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-172	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-172	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-173	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-173	Carbatrol	carbamazepine	Shire US Manufacturing Inc.	NDA	Current
54092-173	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-173	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-173	Carbatrol	carbamazepine	Takeda Pharmaceuticals America, Inc.	NDA	Current
66993-407	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-407	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-407	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-408	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-408	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-408	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-409	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-409	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-409	Carbamazepine	carbamazepine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
69189-0410	Carbamazepine	carbamazepine	Avera McKennan Hospital	NDA AUTHORIZED GENERIC	Current
70518-0124	Carbamazepine	carbamazepine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2524	Carbamazepine	carbamazepine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73981	SUPPL	2023-04-12
73978	SUPPL	2023-04-12
73977	SUPPL	2023-04-12
69465	SUPPL	2021-12-03
69451	SUPPL	2021-12-02
55350	SUPPL	2018-08-28
55335	SUPPL	2018-08-28
43672	SUPPL	2013-05-22
35207	SUPPL	2013-03-26
35206	SUPPL	2013-03-26
3179	SUPPL	2013-03-25
3178	SUPPL	2013-03-25
25612	SUPPL	2011-09-06
3177	SUPPL	2011-02-03
35205	SUPPL	2011-01-31
25611	SUPPL	2009-04-29
13276	SUPPL	2009-04-28
3176	SUPPL	2008-01-09
23978	SUPPL	2007-12-31
13275	SUPPL	2007-12-12
20871	ORIG	2007-04-17
3175	SUPPL	2006-07-13
13274	SUPPL	2006-07-03
3174	SUPPL	2006-01-30