FDA.reportPublic FDA data

Application 217758

Type
ANDA
Sponsor
ZYDUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONIUM LACTATEAMMONIUM LACTATELOTION;TOPICALEQ 12% BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217758-001AMMONIUM LACTATEAMMONIUM LACTATEEQ 12% BASELOTION / TOPICALAB2026-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217758-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217758-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALAB2026-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217758-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium LactateAMMONIUM LACTATEREMEDYREPACK INC.030e8bd1-0ff3-479f-aa77-16fab701a1112026-04-14Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltd7096d38e-2bd1-4374-9bf6-7fd09ef7509c2025-11-30Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.8bb09bb3-5bbc-489d-96c1-ae97cb58381e2025-07-01Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.9745b6ce-f532-4e80-b6e9-477ab9db4e302025-07-01Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltddc3a6462-0f2c-4306-b5ef-c7b47395e9592025-06-30Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack170f8764-a180-49fa-b406-44f5b7921a662024-04-12Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack99a5db95-7b48-46f1-99c7-db1c9ea656812024-02-08Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEA-S Medication Solutionsab54704d-ace2-410c-b0af-2fa13462a8b32023-08-24Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack411b40c7-4d62-4ea4-be69-bea5d1d591ca2023-08-16Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack1d2adae5-0225-4e66-8f4f-14a5ef11e1d02023-07-17Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack2455f1aa-562d-424a-9542-4853adf1ca752023-07-17Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack7a23d405-a48c-482f-9b28-6ae851ccefe32023-07-17Warnings, Adverse reactionsName fallback
brand name: Ammonium Lactate
generic name: AMMONIUM LACTATE