Home Applications 021821 Application 021821
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYGACIL TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021821-001 TYGACIL TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021821-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021821-001 10588975 2026-03-13 Drug product 2020-04-15 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 N021821-001 7879828 2029-02-05 Drug product N021821-001 8372995 2030-10-08 Drug product 2013-02-28
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 · 41 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 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021821-001 TYGACIL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2005-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 242 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021821-001 7879828 2029-02-05 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 7879828 2029-02-05 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021821-001 7879828 2029-02-05 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 7879828 2029-02-05 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 7879828 2029-02-05 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 7879828 2029-02-05 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021821-001 8372995 2030-10-08 Drug product 2013-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021821-001 10588975 2026-03-13 Drug product 2020-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021821-001 9254328 2026-03-13 Drug product 2016-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021821-001 9694078 2026-03-13 Drug product 2017-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021821-001 8975242 2028-10-24 Drug product 2015-03-10 2680178bc6a6…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4990 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-4994 Tygacil TIGECYCLINE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current