FDA.reportPublic FDA data

Application 203203

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203203-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25
A203203-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203203-001AB
A203203-002AB

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
2026-08-01 22:54:322026-06A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25a50c72e98297…
2026-08-01 22:54:322026-06A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203203-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203203-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals Inc.db42468a-450c-4b12-b2f2-e9a76e976d452026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEA-S Medication Solutions3babf7d9-ad83-4e44-8e5d-f6c11b2d76b62025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 50090-6154
LansoprazoleLANSOPRAZOLEA-S Medication Solutions16dc1e02-4679-4d7f-a65b-6e3706655d352025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.37b221ee-b6a4-76e8-e063-6394a90a7e0b2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEGolden State Medical Supply, Inc.a9dd7e56-1aee-5f0b-e053-2995a90a43bf2024-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 51407-324
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.11344047-7ed4-61e7-e063-6394a90a332d2024-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke0299cf2-8a8e-499b-a81e-16e844ea3aff2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepackae03d05b-0a0f-4bae-bbdc-450b7b5f7a922024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 63629-2341
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack44f07613-35be-4673-98f0-4b2467acce9c2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 63629-2340
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack1dc026b6-b521-4a46-9a74-8c1c140d53292024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 63629-2342
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacka612a237-ec17-49f0-8985-44407608adb52023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 71335-1820
LansoprazoleLANSOPRAZOLEXiromed LLC00a574e0-bd03-deea-9f85-b108f78982ba2022-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 70700-263
ndc (product): 70700-262

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6154LansoprazoleLansoprazoleA-S Medication SolutionsANDACurrent
51407-324LansoprazoleLansoprazoleGolden State Medical SupplyANDACurrent
51407-324LansoprazoleLansoprazoleGolden State Medical SupplyANDACurrent
51407-324LansoprazoleLansoprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-324LansoprazoleLansoprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-324LansoprazoleLansoprazoleGolden State Medical Supply, Inc.ANDACurrent
63629-2340LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
63629-2340LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
63629-2341LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
63629-2341LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
63629-2342LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
63629-2342LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-262LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
70700-263LansoprazoleLansoprazoleXiromed LLCANDACurrent
71335-1820LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent
71335-1820LansoprazoleLansoprazoleBryant Ranch PrepackANDACurrent