FDA.reportPublic FDA data

Application 012015

Type
NDA
Sponsor
OAK PHARMS AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COGENTINBENZTROPINE MESYLATEINJECTABLE;INJECTION1MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012015-001COGENTINBENZTROPINE MESYLATE1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N012015-001COGENTIN1MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012015-001COGENTIN1MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012015-001COGENTIN1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04N012015-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012015-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012015-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012015-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012015-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N012015-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012015-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012015-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012015-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N012015-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N012015-001AP1ea99ee380514…

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATEUnit Dose Solutions, Inc.53c02a89-012c-e724-e063-6294a90acc752026-08-17Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.241479dd-91bf-455a-80a1-1bb2d1c8156d2026-07-28Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.01688e6f-7b22-41bf-9a85-1c88d90f99b62026-06-29Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEREMEDYREPACK INC.09e3e099-0b29-4ab5-bf35-5e41355dd4542026-06-23Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENavinta LLCf92fbafa-314d-4449-831f-26108339e6b22026-03-17Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEChartwell RX, LLC.c002005d-a478-48d4-b345-cb87edcb061f2025-12-09Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsName fallback
generic name: BENZTROPINE MESYLATE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-012Benztropine MesylateBenztropine MesylateAkorn, Inc.NDA AUTHORIZED GENERICCurrent
17478-012Benztropine MesylateBenztropine MesylateAkorn, Inc.NDA AUTHORIZED GENERICCurrent
17478-012Benztropine MesylateBenztropine MesylateAkorn, Inc.NDA AUTHORIZED GENERICCurrent
17478-012Benztropine MesylateBenztropine MesylateAkornNDA AUTHORIZED GENERICCurrent
64725-0012Benztropine MesylateBenztropine MesylateTYA PharmaceuticalsNDA AUTHORIZED GENERICCurrent
76478-611Cogentinbenztropine mesylateOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)NDACurrent
76478-611Cogentinbenztropine mesylateOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)NDACurrent
76478-611Cogentinbenztropine mesylateOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73430SUPPL 2023-02-09
11982SUPPL2013-04-24
300SUPPL2013-04-24
33067SUPPL2013-04-22
10790SUPPL2013-04-22
11981SUPPL2001-05-22