Application 074702

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METAPROTERENOL SULFATEMETAPROTERENOL SULFATESYRUP;ORAL10MG/5MLNoNo

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
A074702-001METAPROTERENOL SULFATEMETAPROTERENOL SULFATE10MG/5MLSYRUP / ORAL1997-03-24

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 UTC2022-10A074702-001METAPROTERENOL SULFATE10MG/5MLSYRUP / ORAL1997-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074702-001METAPROTERENOL SULFATE10MG/5MLSYRUP / ORAL1997-03-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074702-001METAPROTERENOL SULFATE10MG/5MLSYRUP / ORAL1997-03-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074702-001METAPROTERENOL SULFATE10MG/5MLSYRUP / ORAL1997-03-24a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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