Application 050504

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MANDOL	CEFAMANDOLE NAFATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	MANDOL	CEFAMANDOLE NAFATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
003	MANDOL	CEFAMANDOLE NAFATE	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No
004	MANDOL	CEFAMANDOLE NAFATE	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N050504-001	MANDOL	CEFAMANDOLE NAFATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
N050504-002	MANDOL	CEFAMANDOLE NAFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
N050504-003	MANDOL	CEFAMANDOLE NAFATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
N050504-004	MANDOL	CEFAMANDOLE NAFATE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050504-001	MANDOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050504-002	MANDOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050504-003	MANDOL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050504-004	MANDOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050504-001	MANDOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050504-002	MANDOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050504-003	MANDOL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050504-004	MANDOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050504-001	MANDOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050504-002	MANDOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050504-003	MANDOL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050504-004	MANDOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050504-001	MANDOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050504-002	MANDOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050504-003	MANDOL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050504-004	MANDOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7771	SUPPL	2003-03-10
7770	SUPPL	2002-07-18