Application 214630

Type: ANDA
Sponsor: BIOCON PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	EQ 180MG BASE	No	No
002	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	EQ 360MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214630-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2021-11-29
A214630-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2021-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214630-001	AB
A214630-002	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 2 · 68 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
2026-08-18 06:07:40	2026-07	A214630-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214630-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214630-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214630-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214630-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214630-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214630-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214630-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214630-001	MYCOPHENOLIC ACID	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214630-002	MYCOPHENOLIC ACID	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214630-001	MYCOPHENOLIC ACID	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214630-002	MYCOPHENOLIC ACID	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214630-001	MYCOPHENOLIC ACID	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214630-002	MYCOPHENOLIC ACID	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214630-001	MYCOPHENOLIC ACID	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214630-002	MYCOPHENOLIC ACID	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214630-001	MYCOPHENOLIC ACID	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214630-002	MYCOPHENOLIC ACID	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2021-11-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214630-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214630-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214630-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214630-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214630-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214630-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214630-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214630-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214630-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214630-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214630-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214630-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214630-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214630-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214630-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214630-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214630-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214630-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214630-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214630-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214630-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214630-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214630-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214630-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214630-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214630-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214630-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214630-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214630-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214630-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214630-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214630-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214630-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214630-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214630-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214630-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214630-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214630-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214630-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214630-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolic Acid	MYCOPHENOLIC ACID	Biocon Pharma Inc.	8516e135-5cc0-ef2d-6dad-0f9f841bb27b	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214630 application number: ANDA214630 ndc (product): 70377-039 ndc (product): 70377-040

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
70377-039	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current
70377-039	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current
70377-039	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current
70377-040	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current
70377-040	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current
70377-040	Mycophenolic Acid	Mycophenolic Acid	Biocon Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76506	ORIG	2023-11-07