Home Applications 217604 Application 217604
Type NDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE;ORAL 105MG 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 N217604-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217604-001 10881617 2038-06-18 Drug product 2024-10-23 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 N217604-001 11478425 2038-06-18 U-4012 Drug product 2024-10-23 N217604-001 11666536 2038-06-18 Drug product 2024-10-23 N217604-001 11911515 2038-06-18 Drug product 2024-10-23 N217604-001 12042559 2038-06-18 Drug product 2024-10-23 N217604-001 12233166 2038-06-18 Drug product 2025-03-17
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.
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 2026-08-18 06:07:40 2026-07 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217604-001 PYRIDOSTIGMINE BROMIDE 105MG TABLET, EXTENDED RELEASE / ORAL 2024-10-04 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 85 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217604-001 10881617 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 11478425 2038-06-18 U-4012 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 11666536 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 11911515 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 12042559 2038-06-18 Drug product 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217604-001 12233166 2038-06-18 Drug product 2025-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217604-001 10881617 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 11478425 2038-06-18 U-4012 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 11666536 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 11911515 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 12042559 2038-06-18 Drug product 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217604-001 12233166 2038-06-18 Drug product 2025-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 10881617 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 11478425 2038-06-18 U-4012 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 11666536 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 11911515 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 12042559 2038-06-18 Drug product 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217604-001 12233166 2038-06-18 Drug product 2025-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217604-001 10881617 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 11478425 2038-06-18 U-4012 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 11666536 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 11911515 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 12042559 2038-06-18 Drug product 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217604-001 12233166 2038-06-18 Drug product 2025-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217604-001 10881617 2038-06-18 Drug product 2024-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217604-001 10925833 2038-06-18 Drug product 2024-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217604-001 10987311 2038-06-18 Drug product 2024-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217604-001 11229606 2038-06-18 Drug product 2024-10-23 fd3edfee7708…
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.
Documents# Document, Submission type, Date table Document Submission type Date 85938 SUPPL 2026-05-18 85903 SUPPL 2026-05-13 83687 ORIG 2025-10-07 79827 ORIG 2024-10-07 79823 ORIG 2024-10-07