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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-208072bd15b7f6…

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
ndc (product): 46122-353
ndc (product): 46122-354
ndc (product): 46122-568
ndc (product): 46122-352
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
ndc (product): 37808-461
ndc (product): 37808-460
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMTopco Associates LLCa631d31d-38e6-1772-8b6d-57672b785d982026-03-06WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 36800-034
ndc (product): 36800-032
ndc (product): 36800-038
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
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): 50090-1694
ndc (product): 50090-1697
ndc (product): 50090-1148
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 0363-1244
ndc (product): 0363-1243
ndc (product): 0363-1245
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMBluePoint Laboratoriesa8a769ce-e41a-696f-e053-2a95a90a6b182025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMCardinal Healthc4cc8321-807f-258f-71f5-e993f633f9e32024-11-18WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
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 (product): 0536-5894
ndc (product): 0536-5895
ndc (product): 0536-5896

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 180 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1240Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1240Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1241Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1241Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1242Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1242Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8000Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8001Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8002Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
11822-1603Nicotine Transdermal SystemNicotine Transdermal SystemRite Aid CorporationANDACurrent
11822-1603Nicotine Transdermal SystemNicotine Transdermal SystemRite Aid CorporationANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
37808-122Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-122Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-123Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-123Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1694NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1697NicotineNicotineA-S Medication SolutionsANDACurrent