FDA.reportPublic FDA data

Application 077370

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo
004GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL8MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077370-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2005-12-23
A077370-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2005-12-23
A077370-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2005-12-23
A077370-004GLIMEPIRIDEGLIMEPIRIDE8MGTABLET / ORALAB2005-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077370-001AB
A077370-002AB
A077370-003AB
A077370-004AB

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 22:54:322026-06A077370-001GLIMEPIRIDE1MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-002GLIMEPIRIDE2MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-003GLIMEPIRIDE4MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-004GLIMEPIRIDE8MGTABLET / ORALAB2005-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077370-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESolco Healthcare U.S., LLC86acdd9e-8637-43e4-8bf7-b3a123b871b82021-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077370
application number: ANDA077370
ndc (product): 43547-395
ndc (product): 43547-396
ndc (product): 43547-394

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
61919-720GLIMEPIRIDEGLIMEPIRIDEDirectRXANDACurrent