FDA.reportPublic FDA data

Application 012827

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROBINULGLYCOPYRROLATETABLET;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ROBINUL FORTEGLYCOPYRROLATETABLET;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N012827-001ROBINULGLYCOPYRROLATE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982
N012827-002ROBINUL FORTEGLYCOPYRROLATE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N012827-001AA
N012827-002AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N012827-001ROBINUL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N012827-002ROBINUL FORTE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N012827-001AA1a50c72e98297…
2026-08-01 22:54:322026-06N012827-002AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack10ea264f-e157-4e13-9d79-b4228daf359d2026-02-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 012827
application number: NDA012827
GlycopyrrolateGLYCOPYRROLATERising Pharma Holdings, Inc.58c4cb1f-59b8-4be9-a222-2264ca077d932025-12-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 012827
application number: NDA012827
ndc (product): 16571-743
ndc (product): 16571-744

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-743GlycopyrrolateGlycopyrrolateRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-743GlycopyrrolateGlycopyrrolateRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-744GlycopyrrolateGlycopyrrolateRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-744GlycopyrrolateGlycopyrrolateRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
59630-200RobinulGlycopyrrolateShionogi Inc.NDACurrent
59630-205Robinul ForteGlycopyrrolateShionogi Inc.NDACurrent
68788-8279GlycopyrrolateGlycopyrrolatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
70199-007RobinulGlycopyrrolateCasper Pharma LLCNDACurrent
70199-007RobinulGlycopyrrolateCasper Pharma LLCNDACurrent
70199-008Robinul ForteGlycopyrrolateCasper Pharma LLCNDACurrent
70199-008Robinul ForteGlycopyrrolateCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72198SUPPL2022-09-30
72168SUPPL2022-09-28
48242SUPPL2017-05-05
40683SUPPL2009-09-14
40682SUPPL2009-09-14
40681SUPPL2009-09-14
40680SUPPL2009-09-14
40679SUPPL2009-09-14
40678SUPPL2009-09-14
20038SUPPL2009-09-14
20037SUPPL2009-09-14
20036SUPPL2009-09-14
20035SUPPL2009-09-14
20034SUPPL2009-09-14
344SUPPL2003-08-06