Application 065173

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	CAPSULE;ORAL	EQ 250MG BASE	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
A065173-001	PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14

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 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065173-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065173-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065173-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065173-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065173-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065173-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065173-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065173-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065173-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065173-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065173-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065173-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065173-001	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065173-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065173-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065173-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065173-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065173-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065173-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065173-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065173-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065173-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065173-001	AA	1	`cb3db0bc1861…`

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
Humatin	PAROMOMYCIN SULFATE	Waylis Therapeutics LLC	a725f022-ec3c-430d-8021-96c861b9893c	2025-11-13	Adverse reactions	Exact identifier application applno (ANDA): 065173 application number: ANDA065173 ndc (product): 80725-250

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
23155-038	Paromomycin Sulfate	Paromomycin Sulfate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-038	Paromomycin Sulfate	Paromomycin Sulfate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
55695-022	Paromomycin Sulfate	Paromomycin Sulfate	Department of State Health Services, Pharmacy Branch	ANDA	Current
69784-510	Humatin	PAROMOMYCIN SULFATE	Woodward Pharma Services LLC	ANDA	Current
76413-147	Paromomycin Sulfate	Paromomycin Sulfate	Central Texas Community Health Centers	ANDA	Current
80725-250	Humatin	PAROMOMYCIN SULFATE	Waylis Therapeutics LLC	ANDA	Current
80725-250	Humatin	PAROMOMYCIN SULFATE	Waylis Therapeutics LLC	ANDA	Current