Application 017874

Type: NDA
Sponsor: GLAXOSMITHKLINE CON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANSDERM SCOP	SCOPOLAMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	1MG/72HR	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N017874-001	TRANSDERM SCOP	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, 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
N017874-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017874-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017874-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017874-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017874-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017874-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017874-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017874-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017874-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017874-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017874-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017874-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017874-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017874-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017874-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017874-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017874-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017874-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017874-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017874-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017874-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017874-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017874-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017874-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017874-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017874-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017874-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017874-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017874-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017874-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017874-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017874-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017874-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017874-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017874-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017874-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017874-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017874-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017874-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017874-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017874-001	AB	1	`3a93d1ddd44b…`

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
Transderm Scop	SCOPOLAMINE	Baxter Healthcare Corporation	b877a694-a1d0-4280-937a-a06820b12a88	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017874 application number: NDA017874 ndc (product): 10019-553

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-4345	Transderm Scop	scopolamine	Novatris Consumer Health, Inc.	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-4346	Transderm Scop	scopolamine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
10019-553	Transderm Scop	Scopalamine	Baxter Healthcare Corporation	NDA	Current
66758-208	Transderm Scop	scopolamine	Sandoz Inc	NDA	Current
66758-208	Transderm Scop	scopolamine	Sandoz Inc	NDA	Current
66758-208	Transderm Scop	scopolamine	Sandoz Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83302	SUPPL	2025-09-08
83301	SUPPL	2025-09-08
77696	SUPPL	2025-06-12
82121	SUPPL	2025-05-01
82071	SUPPL	2025-04-29
77702	SUPPL	2024-03-04
58802	SUPPL	2019-05-21
57875	SUPPL	2019-05-21
57895	SUPPL	2019-03-05
57894	SUPPL	2019-03-05
57878	SUPPL	2019-03-04
57877	SUPPL	2019-03-04
57874	SUPPL	2019-03-04
54542	SUPPL	2018-06-12
54541	SUPPL	2018-06-12
11085	SUPPL	2013-05-30
13943	SUPPL	2013-05-02
40764	SUPPL	2007-07-09
20095	SUPPL	2007-07-09
733	SUPPL	2007-01-16
11084	SUPPL	2003-04-11
11083	SUPPL	2003-04-10
13942	SUPPL	2002-03-22
13941	SUPPL	2001-07-26
732	SUPPL	2001-07-26