Application 200327

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEFLARO	CEFTAROLINE FOSAMIL	POWDER;INTRAVENOUS	400MG/VIAL	Yes	No
002	TEFLARO	CEFTAROLINE FOSAMIL	POWDER;INTRAVENOUS	600MG/VIAL	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
N200327-001	TEFLARO	CEFTAROLINE FOSAMIL	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29
N200327-002	TEFLARO	CEFTAROLINE FOSAMIL	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200327-001	AP
N200327-002	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200327-001	9629861	2030-09-21		Drug product	2017-05-17
N200327-001	8247400	2031-02-10	U-282	Drug product
N200327-002	9629861	2030-09-21		Drug product	2017-05-17
N200327-002	8247400	2031-02-10	U-282	Drug product

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 · 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
2026-10-15 13:18:30	2026-09	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N200327-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200327-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N200327-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200327-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200327-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200327-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200327-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	AP	1	`011fe1cb6892…`
2022-04-04 05:41 UTC	2022-04	N200327-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N200327-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200327-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200327-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200327-002	AP	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 7 of 7 · 248 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200327-001	8247400	2031-02-10	U-282	Drug product		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200327-002	6417175	2022-04-11	U-1676	Drug substance, Drug product		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200327-002	8247400	2031-02-10	U-282	Drug product		`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-001	8247400	2031-02-10	U-282	Drug product		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-002	8247400	2031-02-10	U-282	Drug product		`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

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	N200327-001	NPP	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-002	NPP	2022-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200327-001	NPP	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200327-002	NPP	2022-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200327-001	NPP	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	NPP	2022-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200327-001	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-001	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-002	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-002	NPP	2019-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200327-001	NPP	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200327-002	NPP	2022-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200327-001	NPP	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200327-002	NPP	2022-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200327-001	NPP	2022-09-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200327-002	NPP	2022-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200327-001	NPP	2022-09-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200327-002	NPP	2022-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200327-001	NPP	2022-09-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200327-002	NPP	2022-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200327-001	NPP	2022-09-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N200327-002	NPP	2022-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200327-001	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-001	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-002	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-002	NPP	2019-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200327-001	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-001	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-002	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-002	NPP	2019-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200327-001	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-001	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-002	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-002	NPP	2019-05-27	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N200327-001	NPP	2022-09-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N200327-002	NPP	2022-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200327-001	NPP	2022-09-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200327-002	NPP	2022-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200327-001	NPP	2022-09-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N200327-002	NPP	2022-09-13	`f41ea6bd6efb…`

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
Teflaro	CEFTAROLINE FOSAMIL	Allergan, Inc.	3ecde48b-75a2-4beb-9999-369f3f61bb8a	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200327 application number: NDA200327 ndc (product): 0456-0400 ndc (product): 0456-0600

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0400	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current
0456-0600	Teflaro	ceftaroline fosamil	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69498	SUPPL	2021-12-07
69467	SUPPL	2021-12-03
65427	SUPPL	2020-12-01
65367	SUPPL	2020-11-30
60212	SUPPL	2019-10-03
60016	SUPPL	2019-09-17
40020	SUPPL	2016-06-01
18960	SUPPL	2016-06-01
32022	SUPPL	2016-05-31
9818	SUPPL	2016-05-31
40019	SUPPL	2015-09-04
32021	SUPPL	2015-09-04
32020	SUPPL	2015-09-04
18959	SUPPL	2015-09-04
9817	SUPPL	2015-09-04
40018	SUPPL	2015-03-26
9816	SUPPL	2015-03-23
32019	SUPPL	2013-12-17
18958	SUPPL	2013-12-17
18957	SUPPL	2013-06-04
32018	SUPPL	2013-05-30
18956	SUPPL	2012-10-24
9815	SUPPL	2012-10-24
9814	SUPPL	2012-05-24
40017	SUPPL	2012-05-07
9812	SUPPL	2011-07-06
18954	SUPPL	2011-06-30
9813	SUPPL	2011-03-16
18955	SUPPL	2011-03-14
44820	ORIG	2010-12-14
43345	ORIG	2010-12-13
32017	ORIG	2010-11-03
40016	ORIG	2010-10-29
67065	SUPPL	1900-01-01
62877	SUPPL	1900-01-01
52416	SUPPL	1900-01-01
52415	SUPPL	1900-01-01
52414	SUPPL	1900-01-01
52413	SUPPL	1900-01-01
52412	SUPPL	1900-01-01
52411	SUPPL	1900-01-01
52410	SUPPL	1900-01-01
52409	SUPPL	1900-01-01