Application 022318

Type: NDA
Sponsor: GENZYME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENVELA	SEVELAMER CARBONATE	FOR SUSPENSION;ORAL	800MG/PACKET	Yes	No
002	RENVELA	SEVELAMER CARBONATE	FOR SUSPENSION;ORAL	2.4GM/PACKET	Yes	Yes

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
N022318-001	RENVELA	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		RLD	2009-08-12
N022318-002	RENVELA	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-02-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022318-001	9095509	2030-12-06		Drug product	2016-01-13
N022318-002	9095509	2030-12-06		Drug product	2016-01-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	N022318-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022318-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022318-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022318-001	NPP	2019-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	NPP	2019-11-25	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022318-001	NPP	2019-11-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022318-002	NPP	2019-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022318-001	NPP	2019-11-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022318-002	NPP	2019-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022318-001	NPP	2019-11-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022318-002	NPP	2019-11-25	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Carbonate	SEVELAMER CARBONATE	Sanofi-Aventis U.S. LLC	3abc32fe-1bfc-4759-8f7c-36095e221b06	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022318 application number: NDA022318 ndc (product): 0955-1052 ndc (product): 0955-1054
Renvela	SEVELAMER CARBONATE	Genzyme Corporation	e6328460-a57b-450b-a48c-6dcd4b476360	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022318 application number: NDA022318 ndc (product): 58468-0131 ndc (product): 58468-0132

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
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1052	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1054	Sevelamer Carbonate	Sevelamer Carbonate	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0131	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current
58468-0132	Renvela	SEVELAMER CARBONATE	Genzyme Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62806	SUPPL	2020-05-04
62786	SUPPL	2020-05-01
45997	SUPPL	2016-12-01
45962	SUPPL	2016-11-28
17236	SUPPL	2016-03-14
29588	SUPPL	2016-03-11
38568	SUPPL	2014-12-17
7228	SUPPL	2014-11-28
29587	SUPPL	2011-06-24
38567	SUPPL	2011-06-16
24281	ORIG	2011-02-03
21992	ORIG	2011-02-03
38566	ORIG	2009-10-01
7227	ORIG	2009-08-17