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 4 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 2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085381-001 BUTICAPS 15MG CAPSULE / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085381-002 BUTICAPS 30MG CAPSULE / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085381-003 BUTICAPS 50MG CAPSULE / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085381-004 BUTICAPS 100MG CAPSULE / ORAL Approved before 1982 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.