Application 040872

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENTERMINE RESIN COMPLEX	PHENTERMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE	No	No
002	PHENTERMINE RESIN COMPLEX	PHENTERMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	EQ 30MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040872-001	PHENTERMINE RESIN COMPLEX	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-28
A040872-002	PHENTERMINE RESIN COMPLEX	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-28

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040872-001	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040872-002	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040872-001	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040872-002	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040872-001	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040872-002	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040872-001	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040872-002	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2011-07-28	`a50c72e98297…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1366	Phentermine Resin	Phentermine Resin	Lannett Company, Inc.	ANDA	Current
0527-1398	Phentermine Resin	Phentermine Resin	Lannett Company, Inc.	ANDA	Current