Application 021749

Type
NDA
Sponsor
HAMELN PHARMA PLUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTETATE CALCIUM TRISODIUMPENTETATE CALCIUM TRISODIUMSOLUTION;INHALATION, INTRAVENOUSEQ 1GM BASE/5ML (EQ 200MG BASE/ML)YesYes

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
N021749-001PENTETATE CALCIUM TRISODIUMPENTETATE CALCIUM TRISODIUMEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION, INTRAVENOUSRLD2004-08-11

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 UTC2022-10N021749-001PENTETATE CALCIUM TRISODIUMEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION, INTRAVENOUSRLD2004-08-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021749-001PENTETATE CALCIUM TRISODIUMEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION, INTRAVENOUSRLD2004-08-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021749-001PENTETATE CALCIUM TRISODIUMEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION, INTRAVENOUSRLD2004-08-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021749-001PENTETATE CALCIUM TRISODIUMEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION, INTRAVENOUSRLD2004-08-11a50c72e98297…

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma gmbhNDACurrent
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma plus gmbhNDACurrent
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma plus gmbhNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
16303SUPPL2013-03-26
6113SUPPL2013-03-22
6112SUPPL2005-08-08
42297ORIG2004-10-20
44149ORIG2004-08-11
37578ORIG2004-08-11
28516ORIG2004-08-11
24008ORIG2004-08-11