Home Applications 213132 Application 213132
Type ANDA
Sponsor GLENMARK PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML No No
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 A213132-001 ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22
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.
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 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2021-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2021-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2021-06-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2021-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2021-06-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213132-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION 2021-06-22 a50c72e98297…
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 · 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arformoterol Tartrate ARFORMOTEROL TARTRATE Sun Pharmaceutical Industries, Inc. f1005878-0c48-4b9a-843e-b6cf6b8bb251 2026-04-14 Warnings, Adverse reactions Name fallback brand name: Arformoterol Tartrate generic name: ARFORMOTEROL TARTRATE arformoterol tartrate ARFORMOTEROL TARTRATE Lifestar Pharma LLC e9eb1ac7-57aa-4ef8-aac3-14def5b883d0 2026-01-21 Warnings, Adverse reactions Name fallback brand name: arformoterol tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol tartrate ARFORMOTEROL TARTRATE Alembic Pharmaceuticals Inc. f2feda53-54b9-4e40-8a01-9e7b45cb3d8c 2025-12-22 Warnings, Adverse reactions Name fallback brand name: Arformoterol tartrate generic name: ARFORMOTEROL TARTRATE arformoterol tartrate ARFORMOTEROL TARTRATE NorthStar RxLLC 6a498c49-042f-481f-bc5c-a2fc00dc5668 2025-12-08 Warnings, Adverse reactions Name fallback brand name: arformoterol tartrate generic name: ARFORMOTEROL TARTRATE arformoterol tartrate ARFORMOTEROL TARTRATE Cipla USA Inc. 70071afd-5323-4019-aca5-5534278829dc 2025-08-21 Warnings, Adverse reactions Name fallback brand name: arformoterol tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol Tartrate ARFORMOTEROL TARTRATE Ingenus Pharmaceuticals, LLC 9572582e-8cc2-4d3d-b9dc-c2b8159d71d8 2025-06-05 Warnings, Adverse reactions Name fallback brand name: Arformoterol Tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol Tartrate ARFORMOTEROL TARTRATE Micro Labs Limited 6838a595-19cc-454a-96b9-ff83b93881ae 2025-04-18 Warnings, Adverse reactions Name fallback brand name: Arformoterol Tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol tartrate ARFORMOTEROL TARTRATE Lupin Pharmaceuticals, Inc. cf1f2d1b-0455-4113-9647-507faf49fdd0 2025-03-11 Warnings, Adverse reactions Name fallback brand name: Arformoterol tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol Tartrate Inhalation Solution ARFORMOTEROL TARTRATE Aucta Pharmaceuticals, Inc. 8c0d81db-fbf5-405f-9311-d3d78992d9a3 2025-02-11 Warnings, Adverse reactions Name fallback generic name: ARFORMOTEROL TARTRATE Arformoterol tartrate ARFORMOTEROL TARTRATE Fosun Pharma USA Inc. 26e06ee1-f9d6-5167-e063-6394a90a6d32 2024-10-02 Warnings, Adverse reactions Name fallback brand name: Arformoterol tartrate generic name: ARFORMOTEROL TARTRATE arformoterol tartrate ARFORMOTEROL TARTRATE Dr. Reddy's Laboratories, Inc. d8843369-b0d5-6f0d-1fcd-0c49002df755 2024-09-02 Warnings, Adverse reactions Name fallback brand name: arformoterol tartrate generic name: ARFORMOTEROL TARTRATE Arformoterol Tartrate ARFORMOTEROL TARTRATE American Health Packaging bb1a6643-f280-4f02-a824-0428a2b82d3c 2024-04-01 Warnings, Adverse reactions Name fallback brand name: Arformoterol Tartrate generic name: ARFORMOTEROL TARTRATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68462-833 ARFORMOTEROL TARTRATE arformoterol tartrate GLENMARK PHARMACEUTICALS INC., USA ANDA Current 68462-833 ARFORMOTEROL TARTRATE arformoterol tartrate GLENMARK PHARMACEUTICALS INC., USA ANDA Current