Application 209304

Type: ANDA
Sponsor: TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	CREAM;TOPICAL	EQ 0.1% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog.

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209304-001	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM / TOPICAL	AT	2019-10-18	`3f01610625f2…`

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	A209304-001	AT	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209304-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209304-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209304-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209304-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209304-001	AT	1	`3f01610625f2…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	0cce2238-28d3-4280-b520-ffc3067a2ffa	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	a73a5453-c091-43fd-aae2-d992152363b1	2023-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	A-S Medication Solutions	76fabcd6-4da3-49e3-85a1-ca4fac55a207	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	a8b15217-cccb-2260-e053-2995a90a709d	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Padagis Israel Pharmaceuticals Ltd	4cfbe37e-11d6-46fc-b287-0561387b17b7	2023-01-31	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate in Sodium Chloride	GENTAMICIN SULFATE	Baxter Healthcare Corporation	449c9a41-d61e-49fd-b5e3-d76f74b92acf	2023-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	b59e49e0-640b-43c3-ad07-711d1bb154e9	2022-07-19	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	3a6677a6-def5-443e-82bc-c185d41f03b7	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	a54e5c95-609d-4d66-9573-5d1ac78fa58f	2022-03-04	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	cf4386ba-c62a-4ee8-ab59-1bb2e737a5da	2021-05-01	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentak	GENTAMICIN SULFATE	Proficient Rx LP	aebfe247-cdf7-4acb-97b3-6d4341d7c815	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	2098faaa-7f60-4640-8c37-19456ebba653	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-085	Gentamicin Sulfate	gentamicin sulfate	Teligent Pharma, Inc.	ANDA	Current
63739-055	Gentamicin Sulfate Cream USP, 0.1%	Gentamicin Sulfate	McKesson Corporation	ANDA	Current
70512-036	Gentamicin Sulfate Cream 0.1%	Gentamicin Sulfate Cream 0.1%	Sola Pharmaceuticals	ANDA	Current