FDA.reportPublic FDA data

Application 013055

Type
NDA
Sponsor
TELIGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORFLEXORPHENADRINE CITRATEINJECTABLE;INJECTION30MG/MLYesNo

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
N013055-001NORFLEXORPHENADRINE CITRATE30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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 · 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 UTC2022-10N013055-001NORFLEX30MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N013055-001NORFLEX30MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N013055-001NORFLEX30MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N013055-001NORFLEX30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORPHENADRINE CITRATEORPHENADRINE CITRATEREMEDYREPACK INC.7905e80f-b60b-48e8-8e63-a3e50211bfe42026-08-10Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEPreferred Pharmaceuticals, Inc.8ca9438d-320f-4499-aee7-6b8ca7cccc652026-08-07Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATESt. Mary's Medical Park Pharmacy59000b66-166e-75d2-e053-2a91aa0af3c02026-06-26Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATEORPHENADRINE CITRATEBryant Ranch Prepack1b4e379e-8051-421f-a0f4-ad9e6fb9476a2026-02-26Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication Solutions80ef7fb4-7c50-4d25-915e-f9d4a2ccd1992026-01-20Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.87d78229-f022-4b42-a03c-4e6a985c714f2026-01-07Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATEORPHENADRINE CITRATENorthwind Health Company, LLC106be130-b4f8-5ca1-e063-6294a90a15902026-01-01Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATEORPHENADRINE CITRATELupin Pharmaceuticals, Inc.7b76c8a7-dd0c-481c-8299-26dfd38ce0662025-09-10Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate ERORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCb5a6846a-ebb3-1fdd-e053-2a95a90a41302024-12-31Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATEORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCfc63d413-39bd-409d-e053-6294a90a14632024-12-31Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATELake Erie Medical DBA Quality Care Products LLC233915f1-7d58-4b4c-a2bb-e73179d61d072024-12-16Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch Prepack8408d24e-3948-548d-bb12-b1edf0c05e122024-08-27Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATENuCare Pharmaceuticals, Inc.3eb1b1cc-ed7a-6f0f-e054-00144ff88e882024-08-13Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine citrateORPHENADRINE CITRATEHikma Pharmaceuticals USA Inc.ed406e8a-ec00-4711-ae2b-3c5af4f154382024-08-08Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATERedPharm Drug1cff761d-e594-a9e6-e063-6394a90a1fd52024-07-11Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATESandoz Inc239018ff-cec6-46de-ae9d-26c9ec034a322024-03-22Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LPcf620257-7497-44c1-9853-87f96d262fbd2023-12-01Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATESagent Pharmaceuticalsc8d8596a-b81f-4b83-a2f3-a55922ca4a822023-11-14Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LP37e6a157-5d0d-4887-9a26-ed5521fb08e62019-11-01Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE
Orphenadrine CitrateORPHENADRINE CITRATEActavis Pharma, Inc.aec8ad3a-f717-4e74-b7b9-19debdaad79a2016-07-20Warnings, Adverse reactionsName fallback
generic name: ORPHENADRINE CITRATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10830SUPPL2008-02-14
354SUPPL2008-02-14