FDA.reportPublic FDA data

Application 040653

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1MGNoYes
002GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL2MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040653-001GLYCOPYRROLATEGLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31
A040653-002GLYCOPYRROLATEGLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040653-001AA
A040653-002AA

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31e64feba35796…
2022-09-29 23:25 UTC2022-09A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040653-001GLYCOPYRROLATE1MGTABLET / ORALAARS2006-08-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040653-002GLYCOPYRROLATE2MGTABLET / ORALAARS2006-08-31a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10A040653-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040653-002AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040653-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A040653-002AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040653-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040653-002AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040653-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040653-002AA1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 63629-2206
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLC1f266d77-4f9e-44c9-a000-2f8fea3ac80b2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 49884-066
ndc (product): 49884-065
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackd93a9b2b-708d-4db5-8aae-45fd3a7ca65c2025-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 63629-2207
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 63629-9287
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackfcb295e4-038f-4d4f-8786-4fbcd1d3c2982024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653
ndc (product): 71335-2119
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack33bbc475-2fe3-48ab-8a9d-56d13053593e2024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040653
application number: ANDA040653

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8170GlycopyrrolateglycopyrrolateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8170GlycopyrrolateglycopyrrolateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43227-065GlycopyrrolateGlycopyrrolatePar Formulations Private LimitedANDACurrent
43227-066GlycopyrrolateGlycopyrrolatePar Formulations Private LimitedANDACurrent
49884-065GlycopyrrolateglycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
49884-066GlycopyrrolateglycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
60687-270GlycopyrrolateglycopyrrolateAmerican Health PackagingANDACurrent
63629-2206GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2206GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2207GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2207GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-5442GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-9287GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
64980-272GlycopyrrolateglycopyrrolateRising Pharmaceuticals, Inc.ANDACurrent
64980-273GlycopyrrolateglycopyrrolateRising Pharmaceuticals, Inc.ANDACurrent
71335-2119GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent