Home Applications 074967 Application 074967
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG No No 002 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074967-001 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE / ORAL AB 1997-07-09 A074967-002 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE / ORAL AB 1997-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 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 2026-08-18 06:07:40 2026-07 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 1997-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 1997-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-1650 Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) Mylan Pharmaceuticals Inc. ANDA Current 0615-1308 Nitrofurantoin Nitrofurantoin NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-7655 Nitrofurantoin Nitrofurantoin NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 55289-186 Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) PD-Rx Pharmaceuticals, In ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22392 ORIG 2003-06-17