Home Applications 216774 Application 216774
Type NDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALVAIZ ELTROMBOPAG TABLET; ORAL 9MG No No 002 ALVAIZ ELTROMBOPAG TABLET; ORAL 18MG No No 003 ALVAIZ ELTROMBOPAG TABLET; ORAL 36MG No No 004 ALVAIZ ELTROMBOPAG TABLET;ORAL 54MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216774-001 ALVAIZ ELTROMBOPAG CHOLINE EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 N216774-002 ALVAIZ ELTROMBOPAG CHOLINE EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 N216774-003 ALVAIZ ELTROMBOPAG CHOLINE EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 N216774-004 ALVAIZ ELTROMBOPAG CHOLINE EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22
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 2 of 3 · 84 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 ea1830bbd6c7…
Observed Orange Book patent history# Patent history page 1 of 6 · 204 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 011fe1cb6892…
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 ALVAIZ ELTROMBOPAG Teva Pharmaceuticals, Inc. ed51e463-7a03-4858-bbd2-882ce4753d5a 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216774 application number: NDA216774
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 84808 SUPPL 2026-01-21 84807 SUPPL 2026-01-21 84780 SUPPL 2026-01-20 78850 ORIG 2024-06-20 76701 ORIG 2023-11-30 72242 ORIG 2022-10-04