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 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28bb7c543d1eb4…

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