Application 040688

Type: ANDA
Sponsor: WRASER PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	CAPSULE;ORAL	356.4MG;30MG;16MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040688-001	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	356.4MG;30MG;16MG	CAPSULE / ORAL			2007-04-03

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040688-001	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	356.4MG;30MG;16MG	CAPSULE / ORAL			2007-04-03	`a50c72e98297…`

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66992-340	Trezix	acetaminophen, caffeine, dihydrocodeine bitartrate	WraSer LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53883	ORIG	2018-05-01