Application 021246

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAMIFLU	OSELTAMIVIR PHOSPHATE	FOR SUSPENSION;ORAL	EQ 12MG BASE/ML	No	No
002	TAMIFLU	OSELTAMIVIR PHOSPHATE	FOR SUSPENSION;ORAL	EQ 6MG BASE/ML	Yes	Yes

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

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
N021246-001	TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 12MG BASE/ML	FOR SUSPENSION / ORAL			2000-12-14
N021246-002	TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2011-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021246-002	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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	N021246-001	TAMIFLU	EQ 12MG BASE/ML	FOR SUSPENSION / ORAL			2000-12-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021246-002	TAMIFLU	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2011-03-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021246-001	TAMIFLU	EQ 12MG BASE/ML	FOR SUSPENSION / ORAL			2000-12-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021246-002	TAMIFLU	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2011-03-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021246-001	TAMIFLU	EQ 12MG BASE/ML	FOR SUSPENSION / ORAL			2000-12-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021246-002	TAMIFLU	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2011-03-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021246-001	TAMIFLU	EQ 12MG BASE/ML	FOR SUSPENSION / ORAL			2000-12-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021246-002	TAMIFLU	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2011-03-21	`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	N021246-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021246-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021246-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021246-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021246-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021246-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021246-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021246-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021246-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021246-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021246-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021246-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021246-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021246-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021246-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021246-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021246-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021246-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021246-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021246-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021246-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021246-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021246-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021246-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021246-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021246-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021246-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021246-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021246-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021246-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021246-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021246-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021246-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021246-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021246-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021246-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021246-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021246-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021246-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021246-002	AB	1	`3a93d1ddd44b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021246-001	M-251	2022-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021246-002	M-251	2022-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021246-001	M-251	2022-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021246-002	M-251	2022-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021246-001	M-251	2022-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021246-002	M-251	2022-08-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021246-001	M-251	2022-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021246-002	M-251	2022-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021246-001	M-251	2022-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021246-002	M-251	2022-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021246-001	M-251	2022-08-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021246-002	M-251	2022-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021246-001	M-251	2022-08-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021246-002	M-251	2022-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021246-001	M-251	2022-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021246-002	M-251	2022-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021246-001	M-251	2022-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021246-002	M-251	2022-08-02	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N021246-001	M-251	2022-08-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021246-002	M-251	2022-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021246-001	M-251	2022-08-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021246-002	M-251	2022-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021246-001	M-251	2022-08-02	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021246-002	M-251	2022-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021246-001	M-251	2022-08-02	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021246-002	M-251	2022-08-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021246-001	M-251	2022-08-02	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021246-002	M-251	2022-08-02	`cb3db0bc1861…`

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
Tamiflu	OSELTAMIVIR PHOSPHATE	Genentech, Inc.	ee3c9555-60f2-4f82-a760-11983c86e97b	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021246 application number: NDA021246 ndc (product): 0004-0822

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-0822	Tamiflu	Oseltamivir Phosphate	Genentech, Inc.	NDA	Current
0004-0822	Tamiflu	Oseltamivir Phosphate	Genentech, Inc.	NDA	Current
0004-0822	Tamiflu	Oseltamivir Phosphate	Genentech, Inc.	NDA	Current
0004-0822	Tamiflu	Oseltamivir Phosphate	Genentech, Inc.	NDA	Current
0004-0822	Tamiflu	Oseltamivir Phosphate	Genentech, Inc.	NDA	Current
42254-092	Tamiflu	Oseltamivir Phosphate	Rebel Distributors Corp	NDA	Current
50090-1244	Tamiflu	Oseltamivir Phosphate	A-S Medication Solutions	NDA	Current
50090-1244	Tamiflu	Oseltamivir Phosphate	A-S Medication Solutions	NDA	Current
55045-3198	Tamiflu	oseltamivir phosphate	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68337	SUPPL	2021-08-11
59577	SUPPL	2019-08-05
59571	SUPPL	2019-08-05
56807	SUPPL	2018-12-19
56797	SUPPL	2018-12-19
53668	SUPPL	2018-04-13
53630	SUPPL	2018-04-06
4754	SUPPL	2016-06-22
36447	SUPPL	2016-06-21
42050	SUPPL	2015-07-22
21542	SUPPL	2015-07-20
36443	SUPPL	2014-12-03
27190	SUPPL	2014-11-28
27192	SUPPL	2014-10-16
14724	SUPPL	2014-10-15
21540	SUPPL	2014-07-07
36446	SUPPL	2014-06-03
4753	SUPPL	2014-06-03
44475	SUPPL	2013-08-12
36444	SUPPL	2013-08-12
21543	SUPPL	2013-06-03
21541	SUPPL	2013-06-03
21544	SUPPL	2013-04-08
4752	SUPPL	2013-01-29
36445	SUPPL	2012-12-21
27191	SUPPL	2012-12-21
24189	SUPPL	2012-12-21
4751	SUPPL	2012-08-20
14723	SUPPL	2012-08-17
4750	SUPPL	2011-03-24
36441	SUPPL	2011-03-23
27189	SUPPL	2011-02-09
36442	SUPPL	2011-02-07
4746	SUPPL	2010-12-21
14720	SUPPL	2010-12-16
4749	SUPPL	2010-11-10
36440	SUPPL	2010-11-05
36439	SUPPL	2010-03-03
14722	SUPPL	2010-03-03
27188	SUPPL	2010-02-26
27187	SUPPL	2010-02-26
27183	SUPPL	2009-10-21
4745	SUPPL	2009-10-21
4744	SUPPL	2009-10-21
4742	SUPPL	2009-10-21
27181	SUPPL	2009-10-19
27179	SUPPL	2009-10-19
27178	SUPPL	2009-10-19
4747	SUPPL	2009-10-19
4743	SUPPL	2009-10-19
4741	SUPPL	2009-10-19
4740	SUPPL	2009-10-19
4739	SUPPL	2009-10-19
4738	SUPPL	2009-10-19
4737	SUPPL	2009-10-19
4736	SUPPL	2009-10-16
14721	SUPPL	2009-04-30
4748	SUPPL	2009-04-30
36438	SUPPL	2008-01-18
27186	SUPPL	2008-01-18
27185	SUPPL	2007-10-10
14719	SUPPL	2007-10-10
27184	SUPPL	2007-07-05
14718	SUPPL	2007-07-05
42049	SUPPL	2007-06-22
42048	SUPPL	2007-06-22
42047	SUPPL	2007-06-22
21539	SUPPL	2007-06-22
21538	SUPPL	2007-06-22
21537	SUPPL	2007-06-22
21536	SUPPL	2007-06-22
27182	SUPPL	2006-11-16
36437	SUPPL	2006-11-14
23069	SUPPL	2006-11-14
27180	SUPPL	2006-01-18
23068	SUPPL	2006-01-10
36436	SUPPL	2006-01-05
21535	ORIG	2004-08-09
36435	SUPPL	2004-07-01
27177	SUPPL	2004-07-01
44108	ORIG	2003-12-12
14716	SUPPL	2003-05-01
14715	SUPPL	2003-05-01
14717	SUPPL	2003-04-22
36434	SUPPL	2002-04-26
4735	SUPPL	2002-04-26
14714	ORIG	2000-12-14
4734	ORIG	2000-12-14