Application 078830

Type: ANDA
Sponsor: PERRIGO PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SCOPOLAMINE	SCOPOLAMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	1MG/72HR	No	No

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
A078830-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078830-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`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	A078830-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078830-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078830-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078830-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078830-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078830-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078830-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078830-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078830-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078830-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078830-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078830-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078830-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078830-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078830-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078830-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078830-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078830-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078830-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078830-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078830-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078830-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078830-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078830-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078830-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078830-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078830-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078830-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078830-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078830-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078830-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078830-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078830-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078830-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078830-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078830-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078830-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078830-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078830-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078830-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scopolamine Transdermal System	SCOPOLAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	8455ce88-1270-440b-b62e-fe5fef1415ac	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830
Scopolamine Transdermal System	SCOPOLAMINE TRANSDERMAL SYSTEM	Padagis Israel Pharmaceuticals Ltd	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830 ndc (product): 45802-580
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	81c57d46-1617-4295-8a60-acb7e365551c	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830 ndc (product): 63629-8452
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	1099a330-fcb8-4acd-9ef8-525024c6b9d6	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830 ndc (product): 63629-8451
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	c89cc74e-9506-48e5-bbb7-26b454b498aa	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830 ndc (product): 63629-8450
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	69401d6f-3d18-48b0-b28c-a578c9834f32	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-580	Scopolamine Trandermal System	scolopamine transdermal system	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-580	Scopolamine Trandermal System	scolopamine transdermal system	Perrigo New York Inc	ANDA	Current
45802-580	Scopolamine Trandermal System	scolopamine transdermal system	Perrigo New York Inc	ANDA	Current
63629-8450	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8450	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8450	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8451	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8451	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8451	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8452	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8452	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-8452	Scopolamine Trandermal System	scolopamine transdermal system	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54774	ORIG	2018-07-05
18488	ORIG	2015-02-26
9189	ORIG	2015-02-26