Application 050617

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYGEL	ERYTHROMYCIN	GEL;TOPICAL	2%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050617-001	ERYGEL	ERYTHROMYCIN	2%	GEL / TOPICAL		RLD	1987-10-21

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 · 43 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
2026-09-14 22:38:34	2026-08	N050617-001	ERYGEL	2%	GEL / TOPICAL		RLD	1987-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050617-001	ERYGEL	2%	GEL / TOPICAL		RLD	1987-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050617-001	ERYGEL	2%	GEL / TOPICAL		RLD	1987-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050617-001	ERYGEL	2%	GEL / TOPICAL		RLD	1987-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050617-001	ERYGEL	2%	GEL / TOPICAL	AT	RLD, RS	1987-10-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N050617-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050617-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050617-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050617-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050617-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050617-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050617-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050617-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050617-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050617-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050617-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050617-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050617-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050617-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050617-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050617-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050617-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050617-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050617-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050617-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050617-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050617-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050617-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050617-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050617-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050617-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050617-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050617-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050617-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050617-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050617-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050617-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050617-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050617-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050617-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050617-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050617-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050617-001	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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ery	ERYTHROMYCIN	Bryant Ranch Prepack	0742e636-92b2-48bb-bf01-655e32a61461	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Zydus Lifesciences Limited	76608fdd-1248-4942-9518-fd8076244fa7	2023-06-21		Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	dd64459e-c88f-4ca8-b63b-fb96377a3921	2023-04-01	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	A-S Medication Solutions	1df12239-6957-4b2c-9e65-e2154eafddd0	2023-02-04	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	40edf1bd-42bb-4662-aff6-01fcc133c05d	2022-08-27	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Proficient Rx LP	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	2022-07-01	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Proficient Rx LP	62896bec-669e-4f20-a1e4-4f99afd35d32	2022-04-01	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c	2022-03-07	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	7810e881-5130-4a94-b2e0-9f63f8a7a504	2021-11-30	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Orange Pharmaceuticals USA LLC	379ed8f7-b54f-495f-932e-cd0e4c691134	2021-07-05	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Arbor Pharmaceuticals, Inc.	ddd9ad9a-fc60-409a-a2b3-be51482ef751	2019-03-19	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Wilshire Pharmaceuticals	f2efbc94-64f7-4130-ab23-e5983854f730	2019-01-14	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Arbor Pharmaceuticals, Inc.	ca1326d6-c5c6-4572-96b6-e56cd944799c	2018-12-04	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
ERY-TAB	ERYTHROMYCIN	Arbor Pharmaceuticals, Inc.	fda44eb6-7901-4b80-ba0b-216f6cacf3fd	2018-12-04	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8075	ERYGEL	erythromycin	Mylan Pharmaceuticals Inc.	NDA	Current
0378-8075	ERYGEL	erythromycin	Mylan Pharmaceuticals Inc	NDA	Current
0378-8212	Erythromycin	erythromycin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
40076-415	ERYGEL	erythromycin	Prestium Pharma, Inc.	NDA	Current
40076-415	ERYGEL	erythromycin	Prestium Pharma, Inc.	NDA	Current
40085-315	Erythromycin	erythromycin	Renaissance Pharma, Inc.	NDA AUTHORIZED GENERIC	Current