FDA.reportPublic FDA data

Application 070863

Type
ANDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROSTATNITROGLYCERININJECTABLE;INJECTION5MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A070863-001NITROSTATNITROGLYCERIN5MG/MLINJECTABLE / INJECTION1987-01-08

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A070863-001NITROSTAT5MG/MLINJECTABLE / INJECTION1987-01-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070863-001NITROSTAT5MG/MLINJECTABLE / INJECTION1987-01-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070863-001NITROSTAT5MG/MLINJECTABLE / INJECTION1987-01-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070863-001NITROSTAT5MG/MLINJECTABLE / INJECTION1987-01-08a50c72e98297…

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
nitroglycerinNITROGLYCERINREMEDYREPACK INC.89da40c1-bab1-422e-b326-8ebcbdbc81f32026-09-03Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINREMEDYREPACK INC.b8af0974-33ea-4dd5-9ff7-3b61272aeb252026-09-01Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst9a539019-5f43-1448-e053-2a95a90a3bca2026-08-25Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
nitroglycerinNITROGLYCERINRedpharm Drug594b939f-d399-835e-e063-6294a90a44222026-08-18Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINREMEDYREPACK INC.486f53ce-e3c6-48b0-a6ef-9d08cde387e32026-08-10Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINPadagis Israel Pharmaceuticals Ltd562d2e03-dfed-41ff-8e7f-ec41691419832026-07-06Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINEncube Ethicals, Inc.c17c997b-0e90-4105-888b-2de22d2bf6972026-05-28Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITRO-TIMENITROGLYCERINTIME CAP LABORATORIES, INC3c11c1c2-8e62-4f63-8293-2f8b8d845f7e2026-05-18Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINBryant Ranch Prepack7cf08521-aaf6-4129-9f8e-077d6282fbc62026-05-18Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINSportpharm LLC84739085-81df-4a43-8456-c9edfbf971e92026-04-24Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC4e83a438-1ed6-0a86-e063-6294a90adc8c2026-04-02Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst4b4667e9-3b5e-4dc0-e063-6394a90ac1f52026-03-20Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINGolden State Medical Supply, Inc.df52ab34-e44c-46f3-8c44-2c1bcb93f28e2026-02-19Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINA-S Medication Solutions532e30c4-cbda-4450-b0a0-e08601c202fb2026-02-17Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITRO-BIDNITROGLYCERINSavage Laboratories a division of Fougera Pharmaceuticals, LLCe464e9bb-48e8-4b9f-9fff-e220cfbac0c52026-01-28Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINDr. Reddys Laboratories Incc555f8de-477f-0225-98a2-baf8945bbd632026-01-13Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINAdvagen Pharma Ltd5a36dac2-7d35-4cbf-be3d-705b7135754d2026-01-07Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINGlenmark Pharmaceuticals Inc., USAfa789d65-9407-4965-bd06-4457444b42be2025-12-26Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN

Reported adverse events (FAERS/openFDA)#

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