Application 209408

Type: ANDA
Sponsor: SAMSON MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	POWDER;INTRAVENOUS	EQ 100GM BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 100GM BASE	POWDER / INTRAVENOUS		RS	2018-08-21

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS	RS	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209408-001	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	POWDER / INTRAVENOUS		2018-08-21	`e64feba35796…`

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
CEFEPIME	CEFEPIME	SAMSON MEDICAL TECHNOLOGIES LLC	f776421b-bd46-4664-b9ff-533d805e1277	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209408 application number: ANDA209408 ndc (product): 66288-8100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66288-8100	CEFEPIME	CEFEPIME	SAMSON MEDICAL TECHNOLOGIES LLC	ANDA	Current
66288-8100	CEFEPIME	CEFEPIME	SAMSON MEDICAL TECHNOLOGIES LLC	ANDA	Current
66288-8100	CEFEPIME	CEFEPIME	SAMSON MEDICAL TECHNOLOGIES LLC	ANDA	Current
66288-8100	CEFEPIME	CEFEPIME	SAMSON MEDICAL TECHNOLOGIES LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55406	ORIG	2018-09-07