FDA.reportPublic FDA data

Application 080600

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOLIC ACIDFOLIC ACIDTABLET;ORAL1MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080600-001FOLIC ACIDFOLIC ACID1MGTABLET / ORALApproved before 1982

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080600-001FOLIC ACID1MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080600-001FOLIC ACID1MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080600-001FOLIC ACID1MGTABLET / ORALApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A080600-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A080600-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A080600-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080600-001AA1ea99ee380514…

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22026-09-11Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDREMEDYREPACK INC.368b69a8-a021-47e3-a6d7-e3497d7363b12026-09-04Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsName fallback
brand name: FOLIC ACID
generic name: FOLIC ACID
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsName fallback
brand name: FOLIC ACID
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDAyurax, LLC96618bf8-6c03-4df3-9896-b7ef27ca392a2026-02-11Warnings, Adverse reactionsName fallback
brand name: FOLIC ACID
generic name: FOLIC ACID
QUIOFICFOLIC ACIDSolubiomix, LLCb868b314-591d-458b-be82-2bcd0b73cce12026-02-08Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID

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
53808-0250Folic AcidFOLIC ACIDState of Florida DOH Central PharmacyANDACurrent
63739-110Folic AcidFolic AcidMcKesson Packaging Services Business Unit of McKesson Corporation.ANDACurrent
67046-215Folic AcidFolic AcidContract Pharmacy Services-PAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43160ORIG2007-04-02