Application 089885

Type
ANDA
Sponsor
HERCON PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.4MG/HRNoNo
002NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/HRNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089885-001NITROGLYCERINNITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30
A089885-002NITROGLYCERINNITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A089885-001AB2
A089885-002AB2

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-3084e616aacf4f…
2026-09-14 22:38:342026-08A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-3084e616aacf4f…
2026-08-18 06:07:402026-07A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30caaa826d4ba7…
2026-08-18 06:07:402026-07A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089885-001NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-10-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089885-002NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB22017-10-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A089885-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A089885-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07A089885-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A089885-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089885-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089885-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089885-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089885-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089885-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089885-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089885-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089885-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089885-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089885-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089885-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089885-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089885-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089885-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089885-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089885-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089885-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089885-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089885-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A089885-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089885-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089885-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089885-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089885-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089885-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089885-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089885-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A089885-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089885-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089885-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089885-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A089885-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089885-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A089885-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089885-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089885-002AB2174a2ff9319b5…

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 2 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitroglycerinNITROGLYCERINSolaris Pharma Corporationf0a76edb-9e63-4aa4-9362-7375c799b2b52025-12-22Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
Nitroglycerin In DextroseNITROGLYCERINProPharma Distribution3f2c9570-a544-1982-e063-6294a90a30672025-12-18Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERIN LINGUALNITROGLYCERINAllegis Pharmaceuticals, LLCfadd07b7-189b-4678-ad0f-bf1e4d3d13002025-12-17Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINHenry Schein, Inc.578d8159-5ec6-457f-b4a8-9add624d43a82025-11-06Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst422b4713-9531-f1bf-e063-6294a90ada2b2025-10-27Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINEncube Ethicals, Inc.7bcead76-a90f-4140-9c73-4339d981a0842025-09-26Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC3f7ebc5e-82a7-393d-e063-6394a90a173a2025-09-23Warnings, Adverse reactionsName fallback
brand name: nitroglycerin
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINRedpharm Drug3dd022d8-c224-d19f-e063-6394a90adca42025-09-02Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINProPharma Distribution3d71f76d-bb22-7251-e063-6394a90aa9d82025-08-28Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst9453bd8b-5d54-5dc8-e053-2995a90a95b22025-06-16Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINSolco Healthcare U.S., LLC61759752-dd07-4bed-8079-b578e39305192025-04-30Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
nitroglycerinNITROGLYCERINNorthStar RxLLC141b6098-dd8e-4c99-a581-197d46f9e0b12025-01-17Warnings, Adverse reactionsName fallback
brand name: nitroglycerin
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINNuCare Pharmaceuticals, Inc.2bad7976-4eb0-d064-e063-6394a90a75de2025-01-14Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstc20e89b4-57b5-259d-e053-2a95a90a00382025-01-08Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
nitroglycerinNITROGLYCERINLifestar Pharma LLC38059df3-be1b-4226-9f12-c3c37cb44fea2024-12-30Warnings, Adverse reactionsName fallback
brand name: nitroglycerin
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINTrupharma, LLC543ef8c8-d520-461b-bf6e-f8d8c277feec2024-12-03Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINMylan Pharmaceuticals Inc.041f127e-5166-4484-bc1a-0a373d1187ae2024-10-15Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NITROSTATNITROGLYCERINA-S Medication Solutionsf7059ff7-bf74-48b4-811d-6eb1c26bfd8b2024-08-05Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINNuCare Pharmaceuticals,Inc.f4ea9ad1-a71f-7cea-e053-2a95a90a106d2024-07-22Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINProficient Rx LP41fe1f25-bfd0-4eaf-973d-bdb6b5d70f932024-07-01Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
49730-112Nitroglycerin Transdermal SystemNitroglycerinHercon Laboratories CorporationANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals USA Inc.ANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1477Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1477Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18530ORIG2004-06-10
22704ORIG2003-07-30
9249ORIG1998-10-30