Application 040872

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASENoNo
002PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALEQ 30MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040872-001PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28
A040872-002PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28

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 22:54:322026-06A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28a50c72e98297…
2026-08-01 22:54:322026-06A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28a50c72e98297…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1366Phentermine ResinPhentermine ResinLannett Company, Inc.ANDACurrent
0527-1398Phentermine ResinPhentermine ResinLannett Company, Inc.ANDACurrent