FDA.reportPublic FDA data

Application 085321

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAM-METRAZINEPHENDIMETRAZINE TARTRATETABLET;ORAL35MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A085321-001CAM-METRAZINEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALApproved 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A085321-001CAM-METRAZINE35MGTABLET / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phendimetrazine TartratePHENDIMETRAZINE TARTRATECalvin Scott & Co., Inc.f5c30a88-5814-5b42-e053-2995a90a437a2026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack75f6c4bc-ed72-498a-822c-ecc2a13df9582026-04-01Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsef4cfd54-7d3e-4571-ae77-38ab2fd1af3d2026-01-29Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEAcertis Pharmaceuticals, LLC162140d3-b833-4633-9759-95821a46a6902025-12-19Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCcc9a0cd2-6fb9-47ab-8e39-146d2fa361c22025-12-19Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPreferred Pharmaceuticals Inc.767b5386-1e56-4eeb-8d59-510b940ab75e2025-09-08Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc.342bc2a2-2751-b51a-e063-6394a90a4c432025-05-02Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsf1d265e1-522e-4a62-afda-29477fb94b8d2025-04-04Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack137e5fcd-9536-4fb9-9885-5dfd1127c35a2025-01-30Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.467ae7d7-e342-423b-be89-5d38c1abf3c92025-01-08Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEKVK-TECH, INC07bf3488-09e7-436f-af3f-94c35a7be0252024-12-06Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATENuCare Pharmaceuticals,Inc.05bb0569-4eed-2139-e063-6394a90acb6c2024-09-27Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc,40e5b0bf-347e-30f6-e054-00144ff88e882024-08-14Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEBryant Ranch Prepack1c2370fd-6b40-48dc-a42d-2488041d5b372024-08-08Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutions7adaf128-fef4-4bbf-8b4a-875fe46bf68a2023-07-18Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack8593421c-d1fb-409d-a5bb-3369da18fd2c2023-07-12Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEElite Laboratories, Inc42ecacde-6859-47c6-ba44-13fb4f3b54482019-02-07Warnings, Adverse reactionsName fallback
generic name: PHENDIMETRAZINE TARTRATE