Application 211158

Type: NDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIGECYCLINE	TIGECYCLINE	POWDER;INTRAVENOUS	50MG/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211158-001	TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2018-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N211158-001	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211158-001	9855335	2033-04-07		Drug product	2018-09-19

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 · 42 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	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS		2018-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N211158-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211158-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`e64feba35796…`

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
Tigecycline	TIGECYCLINE	Amneal Pharmaceuticals LLC	8450bd15-2b06-4fc7-b302-9021312e3f0d	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211158 application number: NDA211158 ndc (product): 70121-1647

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
70121-1647	Tigecycline	Tigecycline	Amneal Biosciences LLC	NDA	Current
70121-1647	Tigecycline	Tigecycline	Amneal Pharmaceuticals LLC	NDA	Current
70121-1647	Tigecycline	Tigecycline	Amneal Pharmaceuticals LLC	NDA	Current
70121-1647	Tigecycline	Tigecycline	Amneal Pharmaceuticals LLC	NDA	Current
70121-1647	Tigecycline	Tigecycline	Amneal Pharmaceuticals LLC	NDA	Current
70121-1647	Tigecycline	Tigecycline	Amneal Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81865	SUPPL	2025-04-08
81797	SUPPL	2025-04-02
67485	SUPPL	2021-05-13
65203	SUPPL	2020-11-13
65200	SUPPL	2020-11-12
64190	SUPPL	2020-08-03
64177	SUPPL	2020-08-03
56327	ORIG	2018-11-07
55100	ORIG	2018-08-03
55080	ORIG	2018-08-03