Application 050611

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PCE	ERYTHROMYCIN	TABLET, COATED PARTICLES;ORAL	333MG	Yes	No
002	PCE	ERYTHROMYCIN	TABLET, COATED PARTICLES;ORAL	500MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050611-001	PCE	ERYTHROMYCIN	333MG	TABLET, COATED PARTICLES / ORAL		RLD	1986-09-09
N050611-002	PCE	ERYTHROMYCIN	500MG	TABLET, COATED PARTICLES / ORAL		RLD	1990-08-22

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050611-001	PCE	333MG	TABLET, COATED PARTICLES / ORAL	RLD	1986-09-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050611-002	PCE	500MG	TABLET, COATED PARTICLES / ORAL	RLD	1990-08-22	`3a93d1ddd44b…`

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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Bausch & Lomb Incorporated	061ddd20-94a6-4e3c-ba84-1ebd8529eea6	2026-08-28	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Sportpharm LLC	790d3e3e-df69-45f7-97d5-da65faa46556	2026-07-21	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	50c8d6b3-4660-e829-e063-6294a90a919b	2026-05-01	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Cardinal Health 107, LLC	ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5	2026-04-27	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Golden State Medical Supply, Inc.	0c05e1f7-a3d4-8e69-e063-6394a90aecc3	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Preferred Pharmaceuticals, Inc.	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	2026-04-10	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Sentiss Pharmaceuticals LLC	4da0e351-383f-55da-e063-6394a90a8eba	2026-03-31	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Direct Rx	9ac4dcd2-8cac-404d-b651-da74062d30ed	2026-03-17	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Torrent Pharmaceuticals Limited	933049f6-61b9-4ed5-b6b7-60c5037e2115	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Redpharm Drug	301ee5ad-3b6c-1152-e063-6294a90a54e7	2025-12-23	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	A-S Medication Solutions	2be16639-b153-407b-b43d-3a2bcf66151e	2025-12-03	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Ery	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	9a63da11-01be-4c63-a260-e6bdbb4a7a69	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	PD-Rx Pharmaceuticals, Inc.	e54d66fa-93bb-4339-a75e-194a2e4488aa	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	10ad1391-32fc-40c0-96d0-675f3c91429f	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
ERYTHROMYCIN	ERYTHROMYCIN	Ascend Laboratories, LLC	3b415e31-e5d4-4990-8021-78459af73372	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
erythromycin	ERYTHROMYCIN	Dr. Reddy's Labratories Inc.	a2dcb48a-212c-1b0c-ec35-ee2ade85847f	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	A-S Medication Solutions	99eb7dbc-6ba9-4122-ad1e-5cae73186932	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin Ethylsuccinate	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	581d7430-1a80-42a6-befb-4c3ae8140392	2025-04-25	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Erythromycin	ERYTHROMYCIN	ST. MARY'S MEDICAL PARK PHARMACY	2cc726c2-3746-6dbf-e063-6294a90a789f	2025-01-28	Adverse reactions	Name fallback generic name: ERYTHROMYCIN
Ery	ERYTHROMYCIN	Bryant Ranch Prepack	912f5941-6f70-4b75-9391-76aada88024d	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53808	SUPPL	2018-04-24
53801	SUPPL	2018-04-24
30170	SUPPL	2012-02-06
17930	SUPPL	2012-02-06
30169	SUPPL	2011-02-07
39039	SUPPL	2011-01-31
7886	SUPPL	2010-11-08
17929	SUPPL	2009-01-02
7887	SUPPL	2008-12-19
7885	SUPPL	2008-05-28
7884	SUPPL	2008-01-09
39040	SUPPL	2008-01-08
30167	SUPPL	2006-08-14
39038	SUPPL	2006-08-11
42659	SUPPL	2004-09-21
30168	SUPPL	2004-03-16
30166	SUPPL	2002-04-25