FDA.reportPublic FDA data

Application 020508

Type
NDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAC-HYDRINAMMONIUM LACTATECREAM;TOPICALEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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
N020508-001LAC-HYDRINAMMONIUM LACTATEEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1996-08-29

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020508-001LAC-HYDRINEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1996-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020508-001LAC-HYDRINEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1996-08-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020508-001LAC-HYDRINEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICAL1996-08-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020508-001LAC-HYDRINEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1996-08-29a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium lactateAMMONIUM LACTATEZydus Lifesciences Limited10a894e6-d23a-4142-8c9f-7bf96be9b9912026-10-02Name fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.9745b6ce-f532-4e80-b6e9-477ab9db4e302026-08-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.8bb09bb3-5bbc-489d-96c1-ae97cb58381e2026-07-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEREMEDYREPACK INC.030e8bd1-0ff3-479f-aa77-16fab701a1112026-04-14Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltd7096d38e-2bd1-4374-9bf6-7fd09ef7509c2025-11-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltddc3a6462-0f2c-4306-b5ef-c7b47395e9592025-06-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack170f8764-a180-49fa-b406-44f5b7921a662024-04-12Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack99a5db95-7b48-46f1-99c7-db1c9ea656812024-02-08Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEA-S Medication Solutionsab54704d-ace2-410c-b0af-2fa13462a8b32023-08-24Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack411b40c7-4d62-4ea4-be69-bea5d1d591ca2023-08-16Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack1d2adae5-0225-4e66-8f4f-14a5ef11e1d02023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack2455f1aa-562d-424a-9542-4853adf1ca752023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack7a23d405-a48c-482f-9b28-6ae851ccefe32023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-099Lac Hydrinammonium lactateRanbaxy Laboratories Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12655SUPPL2004-12-30
25075SUPPL2004-12-22
20688SUPPL2001-12-11
34737SUPPL2000-08-25
25074SUPPL2000-08-25