Application 016608

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEGRETOL	CARBAMAZEPINE	TABLET;ORAL	200MG	Yes	Yes

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
N016608-001	TEGRETOL	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016608-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016608-001	TEGRETOL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N016608-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016608-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016608-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016608-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016608-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016608-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016608-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016608-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016608-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016608-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016608-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016608-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016608-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016608-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016608-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016608-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016608-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016608-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016608-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016608-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016608-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016608-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016608-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016608-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016608-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016608-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016608-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016608-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016608-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016608-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016608-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016608-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016608-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016608-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016608-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016608-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016608-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016608-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016608-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016608-001	AB	1	`cb3db0bc1861…`

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
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016608 application number: NDA016608 ndc (product): 0078-0509

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0509	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
70518-1452	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current
70518-1452	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83624	SUPPL	2025-10-02
83616	SUPPL	2025-10-01
83613	SUPPL	2025-10-01
75460	SUPPL	2023-09-14
75453	SUPPL	2023-09-14
53450	SUPPL	2018-03-27
53418	SUPPL	2018-03-26
53150	SUPPL	2018-03-22
10898	SUPPL	2015-09-03
13004	SUPPL	2015-09-01
10900	SUPPL	2014-09-19
459	SUPPL	2014-09-17
13006	SUPPL	2014-01-17
10902	SUPPL	2014-01-17
33181	SUPPL	2013-03-08
13007	SUPPL	2013-03-08
33182	SUPPL	2012-12-13
464	SUPPL	2012-12-13
463	SUPPL	2011-11-10
33179	SUPPL	2011-03-07
10901	SUPPL	2011-03-07
462	SUPPL	2011-03-07
460	SUPPL	2011-03-07
33180	SUPPL	2009-05-12
461	SUPPL	2009-05-01
13005	SUPPL	2008-01-09
44438	SUPPL	2007-12-31
10899	SUPPL	2007-12-12
33178	SUPPL	2007-08-17
458	SUPPL	2007-08-17
20053	SUPPL	2007-03-08
20052	ORIG	2004-12-08
33177	SUPPL	2001-03-07
457	SUPPL	2001-03-07