FDA.reportPublic FDA data

Application 216910

Type
ANDA
Sponsor
QUAGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATESOLUTION;ORAL1MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216910-001GLYCOPYRROLATEGLYCOPYRROLATE1MG/5MLSOLUTION / ORALAA2026-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216910-001AA

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
2026-08-18 06:07:402026-07A216910-001GLYCOPYRROLATE1MG/5MLSOLUTION / ORALAA2026-05-18caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216910-001GLYCOPYRROLATE1MG/5MLSOLUTION / ORALAA2026-05-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216910-001AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216910-001AA1a50c72e98297…

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 3 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.8b4d1798-c0a7-4661-99cd-1e9a23c163862025-10-16Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.960d2dd0-008d-4ec1-ba2e-9388b28b23e22025-10-09Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3f2b4281-55f3-43e3-e063-6294a90a56ba2025-09-18Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEProPharma Distribution3edcc39d-0e29-4585-e063-6394a90ad5122025-09-15Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3edd6a26-dd0f-2411-e063-6394a90affa22025-09-15Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEAlembic Pharmaceuticals Inc.327f8a9e-7730-4f38-a7aa-fbddebddf1732025-08-26Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.225d95b4-7f8f-44c2-8fc2-93b75d9cc6512025-08-18Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPrecision Dose, Inc.e58f860b-e955-4d71-a128-93bd3812b08d2025-08-08Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYRX-PFGLYCOPYRROLATEExela Pharma Sciences, LLC2189f3f5-39dc-4e85-b7c6-9515ded596862025-07-23Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLCa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c62025-06-14Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEAmerican Health Packaging6404fc8e-d109-4950-9dca-c8a85ad90cf32025-05-18Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATELeading Pharma, LLC498bce66-6072-4212-8413-ff9888c58f9c2025-04-25Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC89090b34-470c-478c-be49-1d2bc48a28f82025-04-17Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEAurobindo Pharma Limited4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b82025-04-17Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEAvPAKbd497783-e2d1-130c-e053-2995a90a7fb92025-03-04Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATECaplin Steriles Limited765490fa-8378-40c8-9fa7-b0bfa2e1a0a92025-01-25Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9a3a142c-daaf-79af-e053-2995a90a1c512025-01-08Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9bde90dd-0300-f705-e053-2a95a90a7ea62025-01-08Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackd93a9b2b-708d-4db5-8aae-45fd3a7ca65c2025-01-06Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
CuvposaGLYCOPYRROLATEMerz Pharmaceuticals, LLCd200bd44-9856-4104-a29e-a4cca3db67372024-12-19Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE