Application 050536

Type: NDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYC	ERYTHROMYCIN	CAPSULE, DELAYED REL PELLETS;ORAL	250MG	Yes	Yes

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

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
N050536-001	ERYC	ERYTHROMYCIN	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050536-001	AB

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050536-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050536-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050536-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050536-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050536-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050536-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050536-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050536-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050536-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050536-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050536-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050536-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050536-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050536-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050536-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050536-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050536-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050536-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050536-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050536-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050536-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050536-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050536-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050536-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050536-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050536-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050536-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050536-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050536-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050536-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050536-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050536-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050536-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050536-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050536-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050536-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050536-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050536-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050536-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050536-001	AB	1	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
erythromycin	ERYTHROMYCIN	Dr. Reddy's Labratories Inc.	a2dcb48a-212c-1b0c-ec35-ee2ade85847f	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050536 application number: NDA050536

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
68308-250	erythromycin	erythromycin	Mayne Pharma Inc.	NDA AUTHORIZED GENERIC	Current
68308-250	erythromycin	erythromycin	Mayne Pharma Inc.	NDA AUTHORIZED GENERIC	Current
68308-250	erythromycin	erythromycin	Mayne Pharma Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53811	SUPPL	2018-04-24
53799	SUPPL	2018-04-24
38967	SUPPL	2013-03-26
7794	SUPPL	2013-03-22
30059	SUPPL	2012-02-21
38968	SUPPL	2012-02-17
17856	SUPPL	2008-02-25
7793	SUPPL	2008-02-25
30058	SUPPL	2006-01-20
38966	SUPPL	2006-01-13
30056	SUPPL	2004-02-27
30057	SUPPL	2003-12-22