Home Applications 080927 Application 080927
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE TABLET;ORAL 7.5MG No No 002 PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE TABLET;ORAL 15MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080927-001 PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE 7.5MG TABLET / ORAL Approved before 1982 A080927-002 PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE 15MG TABLET / ORAL Approved before 1982
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A080927-001 PROPANTHELINE BROMIDE 7.5MG TABLET / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A080927-002 PROPANTHELINE BROMIDE 15MG TABLET / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080927-001 PROPANTHELINE BROMIDE 7.5MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080927-002 PROPANTHELINE BROMIDE 15MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080927-001 PROPANTHELINE BROMIDE 7.5MG TABLET / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080927-002 PROPANTHELINE BROMIDE 15MG TABLET / ORAL Approved before 1982 a50c72e98297…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-4721 Propantheline Bromide Propantheline Bromide West-Ward Pharmaceuticals Corp. ANDA Current 0054-4721 Propantheline Bromide Propantheline Bromide West-Ward Pharmaceuticals Corp. ANDA Current 0054-4721 Propantheline Bromide Propantheline Bromide West-Ward Pharmaceuticals Corp. ANDA Current