Application 064184

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	GEL;TOPICAL	2%	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
A064184-001	ERYTHROMYCIN	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1997-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A064184-001	AT

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064184-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	1997-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064184-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064184-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064184-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064184-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064184-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064184-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064184-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064184-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064184-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064184-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064184-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064184-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064184-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064184-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064184-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064184-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064184-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064184-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064184-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064184-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064184-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064184-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064184-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064184-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064184-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064184-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064184-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064184-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064184-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064184-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064184-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064184-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064184-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064184-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064184-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064184-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064184-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064184-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064184-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064184-001	AT	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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ery	ERYTHROMYCIN	Bryant Ranch Prepack	912f5941-6f70-4b75-9391-76aada88024d	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Wilshire Pharmaceuticals	e9b5abbb-2952-44ce-8cbb-415d9be23df4	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	bb641ed4-8093-4e15-9cb9-8921b1093d50	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Golden State Medical Supply, Inc.	0c0560be-fb11-509d-e063-6394a90ab6f7	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: ERYTHROMYCIN generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Torrent Pharmaceuticals Limited	66b0d891-8756-43d1-b046-6dba787dd96f	2024-10-17	Warnings, Adverse reactions	Name fallback brand name: ERYTHROMYCIN generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	00c4f27e-59e2-4173-99b1-59dd295e83de	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	5568ade8-bdc2-1a32-e054-00144ff8d46c	2024-08-14	Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Teva Pharmaceuticals USA, Inc.	75a0bd5a-d09f-483b-bfd8-f8343b149eb2	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: erythromycin generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	84119a8f-78d1-2882-e053-2a91aa0a6faa	2024-06-14	Adverse reactions	Name fallback brand name: erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	6296e2ed-334c-b9af-e053-2991aa0aae0c	2024-06-06	Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Zydus Pharmaceuticals USA Inc.	0277341c-8513-4317-9334-c242f97630c1	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Nivagen Pharmaceuticals, Inc.	aa61cb37-5fc5-4225-b894-1d660386777f	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: ERYTHROMYCIN generic name: ERYTHROMYCIN
Erythromycin Ethylsuccinate	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	596fa019-b0eb-4e57-93ff-195a765a2e91	2023-12-29	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Modavar Pharmaceuticals LLC	bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0	2023-12-23	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Cadila Pharmaceuticals Limited	fae8fc38-3c60-43b8-a0f9-2c50df332505	2023-12-22	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Fera Pharmaceuticals, LLC	be59bb85-8ef4-4f9e-85e5-c05662ecd1ee	2023-10-26		Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	ARMAS PHARMACEUTICALS INC.	07fdeac5-f690-d74b-e063-6394a90a5c5b	2023-10-23	Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	6186510d-62ca-4083-9895-8d028d71b510	2023-09-12	Adverse reactions	Name fallback brand name: erythromycin generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Alembic Pharmaceuticals Limited	904b9ab6-9a2a-47f3-8a38-04920ce696e0	2023-08-29	Warnings, Adverse reactions	Name fallback brand name: Erythromycin generic name: ERYTHROMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0216	Erythromycin	erythromycin	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0216	Erythromycin	erythromycin	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22298	ORIG	2011-03-10