FDA.reportPublic FDA data

Application 074612

Type
ANDA
Sponsor
AVEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HRNoNo
002NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HRNoNo
003NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HRNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074612-001NICOTINENICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20
A074612-002NICOTINENICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28
A074612-003NICOTINENICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-201e350fbaab3a…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMIngenus Pharmaceuticals, LLC0c25e8b8-7202-459b-85ac-0d757f344b342026-05-20WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAmerisourceBergen Drug Corporation8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e2026-03-31WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMQuitine LLCe4761ed6-509b-4e43-88e0-b0229d24859a2026-03-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMH-E-Bda35e19d-b0aa-8a5f-140e-7601bd2027fe2026-03-06WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMTopco Associates LLCa631d31d-38e6-1772-8b6d-57672b785d982026-03-06WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEMeijer, Inc.78b85047-b412-44fa-91e1-a1c891d478762026-01-22WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems, Inc.55442645-fa9b-4a9b-81e2-345ad062a1242025-11-18WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
MedlineNICOTINEMedline Industries, LPe11a4b7e-6f1f-24db-e053-2a95a90a0d092025-11-04WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 53329-192
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems Inc.7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe2025-07-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEStrategic Sourcing Services LLCa08022ff-e412-47f9-8132-318f55528c5c2025-07-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEA-S Medication Solutions13aa171e-7425-47fc-b618-7759840f06182025-05-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 50090-1697
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMBluePoint Laboratoriesa8a769ce-e41a-696f-e053-2a95a90a6b182025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 68001-433
ndc (product): 68001-432
ndc (product): 68001-434
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMCardinal Healthc4cc8321-807f-258f-71f5-e993f633f9e32024-11-18WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 70000-0511
ndc (product): 70000-0510
foster and thrive STEP 3NICOTINE TRANSDERMAL SYSTEMStrategic Sourcing Services LLCd992645a-f185-48be-887a-e89ab5fcf0392024-06-11WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINERugby Laboratories2dd4cbda-5c46-4655-b69d-21b7d2e912cf2024-06-05WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 180 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1697NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1697NicotineNicotineA-S Medication SolutionsANDACurrent
53329-192MedlinenicotineMedline Industries, LPANDACurrent
53329-192MedlinenicotineMedline Industries, LPANDACurrent
53329-192MedlinenicotineMedline Industries, LPANDACurrent
58118-9842NicotineNicotineClinical Solutions WholesaleANDACurrent
60505-7064Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7064Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7064Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7065Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7065Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7065Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7066Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7066Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7066Nicotine Transdermal SystemNicotine Transdermal SystemApotex CorpANDACurrent
60505-7088Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7088Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7088Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7089Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7089Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7089Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7090Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7090Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7090Nicotine Transdermal SystemNicotine Transdermal SystemApotex Corp.ANDACurrent
60505-7091NicotineNicotineApotex Corp.ANDACurrent
60505-7091NicotineNicotineApotex Corp.ANDACurrent
60505-7091NicotineNicotineApotex Corp.ANDACurrent
60505-7092NicotineNicotineApotex Corp.ANDACurrent
60505-7092NicotineNicotineApotex Corp.ANDACurrent
60505-7092NicotineNicotineApotex Corp.ANDACurrent
60505-7093NicotineNicotineApotex Corp.ANDACurrent
60505-7093NicotineNicotineApotex Corp.ANDACurrent
60505-7093NicotineNicotineApotex Corp.ANDACurrent
61715-085Nicotine Transdermal SystemNicotinePreferred Plus (Kinray)ANDACurrent
61715-086Nicotine Transdermal SystemNicotinePreferred Plus (Kinray)ANDACurrent
61715-087Nicotine Transdermal SystemNicotinePreferred Plus (Kinray)ANDACurrent
62011-0349NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0349NicotineNicotineMcKesson (Healthmart)ANDACurrent
62011-0349NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0349NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0349NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0350NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0350NicotineNicotineMcKesson (Healthmart)ANDACurrent
62011-0350NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0350NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0350NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0351NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0351NicotineNicotineMcKesson (Healthmart)ANDACurrent
62011-0351NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0351NicotineNicotineStrategic Sourcing Services LLCANDACurrent
62011-0351NicotineNicotineStrategic Sourcing Services LLCANDACurrent
63868-190Nicotine Transdermal SystemNicotineChain Drug Marketing Association Inc.ANDACurrent
63868-191Nicotine Transdermal SystemNicotineChain Drug Marketing Association Inc.ANDACurrent
64725-5895NicotineNicotineTYA PharmaceuticalsANDACurrent
64725-5896NicotineNicotineTYA PharmaceuticalsANDACurrent
68001-432Nicotine Transdermal SystemNicotine Transdermal SystemBluePoint LaboratoriesANDACurrent
68001-433Nicotine Transdermal SystemNicotine Transdermal SystemBluePoint LaboratoriesANDACurrent
68001-434Nicotine Transdermal SystemNicotine Transdermal SystemBluePoint LaboratoriesANDACurrent
68016-288Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-288Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-288Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-288Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-289Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-289Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-289Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-289Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-290Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-290Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-290Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
68016-290Nicotine Transdermal SystemNicotineChain Drug Consortium, LLCANDACurrent
70000-0510Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0510Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0510Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0510Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0510Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0511Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0511Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0511Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0511Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent
70000-0511Nicotine Transdermal SystemNicotine Transdermal SystemCardinal HealthANDACurrent