Application 065129

Type: ANDA
Sponsor: LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	FOR SUSPENSION;ORAL	100MG/5ML	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065129-001	SUPRAX	CEFIXIME	100MG/5ML	FOR SUSPENSION / ORAL			2004-02-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A065129-001	SUPRAX	100MG/5ML	FOR SUSPENSION / ORAL	2004-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065129-001	SUPRAX	100MG/5ML	FOR SUSPENSION / ORAL	2004-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065129-001	SUPRAX	100MG/5ML	FOR SUSPENSION / ORAL	2004-02-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065129-001	SUPRAX	100MG/5ML	FOR SUSPENSION / ORAL	2004-02-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065129-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065129-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065129-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065129-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	6d68dbd9-7d75-4ff1-91db-79ff8ae879ec	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065129 application number: ANDA065129 ndc (product): 68180-416 ndc (product): 68180-405

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-202	SUPRAX	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-202	SUPRAX	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-202	SUPRAX	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-405	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-405	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-405	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-416	CEFIXIME	CEFIXIME	Lupin Pharmaceuticals, Inc.	ANDA	Current