Application 087907

Type
ANDA
Sponsor
ARMSTRONG PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINEPHRINEEPINEPHRINEAEROSOL, METERED;INHALATION0.2MG/INHNoNo

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
A087907-001EPINEPHRINEEPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23f41ea6bd6efb…

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 4 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EpinephrineEPINEPHRINEA-S Medication Solutionsb7a4171c-7934-4723-a140-bd93ea84aae12023-11-21Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC093312af-6eed-1f4b-e063-6294a90a155d2023-11-02Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
epinephrineEPINEPHRINEAmerican Regent, Inc.6add7604-71f6-4d8a-9447-17ad01fa839d2023-10-01Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE
EPIPENEPINEPHRINEAsclemed USA, Inc.311af6d9-20c0-4b87-b236-4185bfa499882023-08-29Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
AdrenalinumEPINEPHRINEBoiron84b2e61b-7c92-5a2e-e053-2a91aa0a626c2023-07-12Name fallback
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab2023-05-22Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC6bdca08a-65bf-f56c-e053-2a91aa0a56d82023-05-22Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEMedical Purchasing Solutions, LLCb622a9b9-2f09-46e4-e053-2995a90aae012023-05-04Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEMedical Purchasing Solutions, LLCc4327095-3a89-d86a-e053-2a95a90ac2552023-04-27Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
Auvi-QEPINEPHRINEMedical Purchasing Solutions, LLC8f110633-bf37-458d-e053-2a95a90a8fa92023-04-26Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
Auvi-QEPINEPHRINEMedical Purchasing Solutions, LLC8f00231e-be88-49fe-e053-2a95a90ab6dd2023-04-26Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEAmerican Regent, Inc.61cacda5-64ee-45ca-b94c-e8640c43e5812023-04-01Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EPIPENEPINEPHRINEViatris Specialty LLC7560c201-9246-487c-a13b-6295db04274a2023-02-15Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEViatris Specialty LLC778ac6ae-6bcb-47a4-bcb3-8dd0da9f88362023-02-15Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst75dbc3f5-9caf-9f55-e053-2a91aa0a47192022-12-09Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst75e96faa-545b-52d6-e053-2991aa0a8fb82022-12-09Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC677c33a2-4e16-406e-e053-2991aa0a45942022-10-13Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEAsclemed USA, Inc.099bc72c-8ffe-4b8c-9608-044c864982fb2022-10-12Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINETeva Pharmaceuticals USA, Inc.04f07f15-55e2-411b-abb8-07eab37f56642021-01-31Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.