Home Applications 040512 Application 040512
Type ANDA
Sponsor ANI PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE TABLET;ORAL 60MG No No 002 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE TABLET;ORAL 30MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040512-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 A040512-002 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040512-001 AB
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 3 · 82 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 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 782e0a99824c…
Observed Orange Book normalized TE history# 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 42631 ORIG 2007-04-02