Home Applications 209816 Application 209816
Type NDA
Sponsor PARATEK PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUZYRA OMADACYCLINE TOSYLATE TABLET;ORAL EQ 150MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N209816-001 NUZYRA OMADACYCLINE TOSYLATE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209816-001 10124014 2029-03-05 U-2449 2018-12-11 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 N209816-001 10383884 2037-10-31 U-2576 2019-09-17 N209816-001 10835542 2037-10-31 U-2576 2020-12-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209816-001 NCE 2023-10-02 N209816-001 GAIN 2028-10-02 N209816-001 M-320 2029-05-13
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 · 43 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 2026-09-14 22:38:34 2026-08 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209816-001 NUZYRA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-02 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 11 · 409 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209816-001 10124014 2029-03-05 U-2449 2018-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 10383884 2037-10-31 U-2576 2019-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209816-001 10835542 2037-10-31 U-2576 2020-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209816-001 10124014 2029-03-05 U-2449 2018-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 10383884 2037-10-31 U-2576 2019-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209816-001 10835542 2037-10-31 U-2576 2020-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209816-001 10124014 2029-03-05 U-2449 2018-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 10383884 2037-10-31 U-2576 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209816-001 10835542 2037-10-31 U-2576 2020-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 7553828 2025-06-02 Drug substance 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 10124014 2029-03-05 U-2449 2018-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 10383884 2037-10-31 U-2576 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209816-001 10835542 2037-10-31 U-2576 2020-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209816-001 7553828 2025-06-02 Drug substance 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 10124014 2029-03-05 U-2449 2018-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 9724358 2029-03-05 U-1569 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 8383610 2030-09-23 Drug substance 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 9265740 2030-10-24 U-1569 Drug product 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 9314475 2031-03-18 Drug product 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209816-001 10111890 2037-08-03 U-2444 2018-11-28 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 89 observed states.
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 NUZYRA OMADACYCLINE Paratek Pharmaceuticals, Inc. 51591524-4703-44c6-8bde-dce3e6a463d1 2026-05-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 209816 application number: NDA209816 ndc (product): 71715-002
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current 71715-002 NUZYRA omadacycline Paratek Pharmaceuticals, Inc. NDA Current