Home Applications 085381 Application 085381
Type ANDA
Sponsor MEDPOINTE PHARM HLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUTICAPS BUTABARBITAL SODIUM CAPSULE;ORAL 15MG No No 002 BUTICAPS BUTABARBITAL SODIUM CAPSULE;ORAL 30MG No No 003 BUTICAPS BUTABARBITAL SODIUM CAPSULE;ORAL 50MG No No 004 BUTICAPS BUTABARBITAL SODIUM CAPSULE;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085381-001 BUTICAPS BUTABARBITAL SODIUM 15MG CAPSULE / ORAL Approved before 1982 A085381-002 BUTICAPS BUTABARBITAL SODIUM 30MG CAPSULE / ORAL Approved before 1982 A085381-003 BUTICAPS BUTABARBITAL SODIUM 50MG CAPSULE / ORAL Approved before 1982 A085381-004 BUTICAPS BUTABARBITAL SODIUM 100MG CAPSULE / 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 2 of 5 · 176 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.