Application 210729

Type: ANDA
Sponsor: ORIENT PHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 125MG BASE	No	No
002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210729-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB		2019-04-29
A210729-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB		2019-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210729-001	AB
A210729-002	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 1 of 3 · 82 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	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210729-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210729-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210729-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210729-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210729-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210729-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210729-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210729-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210729-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210729-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210729-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210729-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210729-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210729-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210729-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210729-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210729-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210729-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7bbd2c81-33d9-4397-8795-8b9fa28cb5cf	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	d6b8147b-5f93-49ee-8b27-78fe58987c90	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Cameron Pharmaceuticals	bc737938-ae36-460b-a2a8-609f3fe59156	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
76333-264	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd	ANDA	Current
76333-264	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd	ANDA	Current
76333-264	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd Yunlin Plant	ANDA	Current
76333-264	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd Yunlin Plant	ANDA	Current
76333-265	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd	ANDA	Current
76333-265	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd	ANDA	Current
76333-265	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd Yunlin Plant	ANDA	Current
76333-265	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Orient Pharma Co.,Ltd Yunlin Plant	ANDA	Current