Application 021985

Type: NDA
Sponsor: NODEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEKTURNA	ALISKIREN HEMIFUMARATE	TABLET;ORAL	EQ 150MG BASE	Yes	No
002	TEKTURNA	ALISKIREN HEMIFUMARATE	TABLET;ORAL	EQ 300MG BASE	Yes	Yes

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
N021985-001	TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05
N021985-002	TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021985-001	AB
N021985-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N021985-001	8617595	2026-02-19	Drug product
N021985-001	8617595*PED	2026-08-19	Pediatric extension
N021985-002	8617595	2026-02-19	Drug product
N021985-002	8617595*PED	2026-08-19	Pediatric extension

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 · 84 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
2026-08-18 06:07:40	2026-07	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N021985-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021985-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021985-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021985-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021985-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021985-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021985-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021985-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021985-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021985-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021985-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021985-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021985-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-08-18 06:07:40	2026-07	N021985-001	8617595	2026-02-19	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	8617595	2026-02-19	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	8617595	2026-02-19	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	8617595	2026-02-19	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	8617595	2026-02-19	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	8617595	2026-02-19	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	8617595	2026-02-19	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	8617595	2026-02-19	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	8617595	2026-02-19	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	8617595	2026-02-19	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	8617595	2026-02-19	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	8617595	2026-02-19	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	8617595	2026-02-19	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	8617595	2026-02-19	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	8617595	2026-02-19	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	8617595	2026-02-19	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	8617595	2026-02-19	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	8617595	2026-02-19	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	8617595	2026-02-19	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	8617595	2026-02-19	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`d8e5a09893c0…`

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
Tekturna	ALISKIREN HEMIFUMARATE	LXO US Inc.	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	2024-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021985 application number: NDA021985 ndc (product): 70839-300 ndc (product): 70839-150
Aliskiren	ALISKIREN HEMIFUMARATE	Prasco Laboratories	41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021985 application number: NDA021985 ndc (product): 66993-141 ndc (product): 66993-142

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1250	Tekturna	aliskiren hemifumarate	A-S Medication Solutions	NDA	Current
50090-2985	Tekturna	aliskiren hemifumarate	A-S Medication Solutions	NDA	Current
50090-2985	Tekturna	aliskiren hemifumarate	A-S Medication Solutions	NDA	Current
66993-141	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-141	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-141	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-142	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-142	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-142	Aliskiren	aliskiren hemifumarate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70839-150	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-150	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-150	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-150	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-150	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-300	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-300	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-300	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-300	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current
70839-300	Tekturna	aliskiren hemifumarate	Noden Pharma USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63673	SUPPL	2020-06-23
63624	SUPPL	2020-06-19
50518	SUPPL	2017-11-29
50422	SUPPL	2017-11-15
45832	SUPPL	2016-11-18
45851	SUPPL	2016-11-08
53028	SUPPL	2016-08-09
53027	SUPPL	2016-08-09
53026	SUPPL	2016-08-09
52974	SUPPL	2016-08-09
16692	SUPPL	2015-12-28
6590	SUPPL	2015-12-23
37997	SUPPL	2015-04-02
6589	SUPPL	2015-04-01
37996	SUPPL	2014-03-19
6588	SUPPL	2013-11-07
37995	SUPPL	2013-11-04
44165	ORIG	2012-11-23
28979	SUPPL	2012-10-02
37994	SUPPL	2012-10-01
52973	SUPPL	2012-08-06
28978	SUPPL	2012-04-18
37993	SUPPL	2012-04-16
28977	SUPPL	2012-02-07
37992	SUPPL	2012-02-06
37991	SUPPL	2012-01-31
28976	SUPPL	2012-01-31
16691	SUPPL	2011-10-20
6587	SUPPL	2011-10-17
28975	SUPPL	2011-02-14
37990	SUPPL	2011-02-11
6586	SUPPL	2010-08-10
16690	SUPPL	2010-08-04
6585	SUPPL	2010-01-25
16689	SUPPL	2009-11-16
52971	SUPPL	2009-03-13
28974	SUPPL	2008-05-21
52975	SUPPL	2008-05-13
6584	SUPPL	2008-02-20
28973	SUPPL	2007-08-14
42368	ORIG	2007-04-30
28972	ORIG	2007-03-15
16688	ORIG	2007-03-07
63847	ORIG	1900-01-01