Application 074612

Type: ANDA
Sponsor: AVEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTINE	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	21MG/24HR	No	No
002	NICOTINE	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7MG/24HR	No	No
003	NICOTINE	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	14MG/24HR	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	Approval date
A074612-001	NICOTINE	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20
A074612-002	NICOTINE	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28
A074612-003	NICOTINE	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Ingenus Pharmaceuticals, LLC	0c25e8b8-7202-459b-85ac-0d757f344b34	2026-05-20	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	AmerisourceBergen Drug Corporation	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	2026-03-31	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Quitine LLC	e4761ed6-509b-4e43-88e0-b0229d24859a	2026-03-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	H-E-B	da35e19d-b0aa-8a5f-140e-7601bd2027fe	2026-03-06	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Topco Associates LLC	a631d31d-38e6-1772-8b6d-57672b785d98	2026-03-06	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Meijer, Inc.	78b85047-b412-44fa-91e1-a1c891d47876	2026-01-22	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Aveva Drug Delivery Systems, Inc.	55442645-fa9b-4a9b-81e2-345ad062a124	2025-11-18	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Medline	NICOTINE	Medline Industries, LP	e11a4b7e-6f1f-24db-e053-2a95a90a0d09	2025-11-04	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Aveva Drug Delivery Systems Inc.	7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe	2025-07-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Strategic Sourcing Services LLC	a08022ff-e412-47f9-8132-318f55528c5c	2025-07-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612 ndc (product): 70677-0031 ndc (product): 70677-0030 ndc (product): 70677-0032
Nicotine Transdermal System	NICOTINE	EXELAN PHARMACEUTICALS, INC.	5aeb4f5c-7cc4-4532-b76e-53bdee8e7220	2025-06-01	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	A-S Medication Solutions	13aa171e-7425-47fc-b618-7759840f0618	2025-05-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Walgreens	5aadb95f-428c-b637-01f4-50d5866ced0c	2025-03-25	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	BluePoint Laboratories	a8a769ce-e41a-696f-e053-2a95a90a6b18	2025-03-25	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Cardinal Health	c4cc8321-807f-258f-71f5-e993f633f9e3	2024-11-18	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612 ndc (product): 70000-0512
foster and thrive STEP 3	NICOTINE TRANSDERMAL SYSTEM	Strategic Sourcing Services LLC	d992645a-f185-48be-887a-e89ab5fcf039	2024-06-11	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Rugby Laboratories	2dd4cbda-5c46-4655-b69d-21b7d2e912cf	2024-06-05	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612

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 3 of 3 · 180 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70000-0512	Nicotine Transdermal System	Nicotine Transdermal System	Cardinal Health	ANDA	Current
70000-0512	Nicotine Transdermal System	Nicotine Transdermal System	Cardinal Health	ANDA	Current
70000-0512	Nicotine Transdermal System	Nicotine Transdermal System	Cardinal Health	ANDA	Current
70000-0512	Nicotine Transdermal System	Nicotine Transdermal System	Cardinal Health	ANDA	Current
70000-0512	Nicotine Transdermal System	Nicotine Transdermal System	Cardinal Health	ANDA	Current
70677-0030	Nicotine	Nicotine	McKesson (Sunmark)	ANDA	Current
70677-0030	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0030	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0030	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0030	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0031	Nicotine	Nicotine	McKesson (Sunmark)	ANDA	Current
70677-0031	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0031	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0031	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0031	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0032	Nicotine	Nicotine	McKesson (Sunmark)	ANDA	Current
70677-0032	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0032	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0032	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current
70677-0032	Nicotine	Nicotine	Strategic Sourcing Services LLC	ANDA	Current