FDA.reportPublic FDA data

Application 076648

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL75MG;25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORAL2004-03-22

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 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22c2088c7a36db…
2026-09-14 22:38:342026-08A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-2284e616aacf4f…
2026-08-18 06:07:402026-07A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-223f01610625f2…
2019-09-15 20:21 UTC2019-09A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2004-03-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076648-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2004-03-223a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076648-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076648-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076648-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076648-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076648-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076648-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076648-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076648-001AB1ea99ee380514…

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Jubilant Cadista Pharmaceuticals Inc.1f7a9414-5592-f2ca-e063-6394a90a75f42025-06-30Warnings, Adverse reactionsName fallback
brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack63a4b367-bf4b-4b5f-b3e9-394ba307886d2025-04-10Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NCS HealthCare of KY, LLC dba Vangard Labsd1825b58-2c00-475d-8d9b-cc07c66383f52025-01-15Warnings, Adverse reactionsName fallback
brand name: NITROFURANTOIN (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Asclemed USA, Inc.ee3f300a-d6d3-49c4-bd60-425f04d30b882025-01-09Warnings, Adverse reactionsName fallback
brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.68a651f9-1aef-792e-e053-2991aa0a3cbb2024-12-30Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN MONOHYDRATE/MACROCRYSTALSAmneal Pharmaceuticals LLC55c75f27-b5fc-4f19-8607-08f8ec0c69ec2024-10-30Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Jubilant Cadista Pharmaceuticals Inc.266824c7-7e9f-4c5f-b642-3bb7bf1c4fe62024-08-27Warnings, Adverse reactionsName fallback
brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPf49f586a-79f0-4731-97f9-9aeb0839ece52024-08-19Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.6bccbaab-151b-4a04-e053-2991aa0ae1052024-06-10Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Sandoz Inc7ba9a729-a73a-4a13-a336-0284cc8a67e12024-02-28Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack05f4b126-0fb9-5ee9-c89c-f229e60f84e32023-11-09Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NorthStar RxLLCd1c778b5-70df-4312-976b-d0bca0cb602a2023-10-05Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Asclemed USA, Inc.1ab658f0-021a-46a1-bff3-d3334c23442d2022-09-21Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPd802d734-dc8f-4f3c-bce6-aaccc4614c892022-09-01Warnings, Adverse reactionsName fallback
brand name: Nitrofurantoin (monohydrate/macrocrystals)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3422Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin, macrocrystallineMylan Pharmaceuticals Inc.ANDACurrent
51079-348Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin macrocrystallineMylan Institutional Inc.ANDACurrent
76413-115Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin, macrocrystallineCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43094ORIG2016-03-09
8942ORIG2004-03-24