Application 010093

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	BIPHETAMINE 20	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE;EQ 10MG BASE	No	No
007	BIPHETAMINE 12.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	EQ 6.25MG BASE;EQ 6.25MG BASE	No	No
009	BIPHETAMINE 7.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	CAPSULE, EXTENDED RELEASE;ORAL	EQ 3.75MG BASE;EQ 3.75MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N010093-003	BIPHETAMINE 20	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982
N010093-007	BIPHETAMINE 12.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982
N010093-009	BIPHETAMINE 7.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / 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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N010093-009	BIPHETAMINE 7.5	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010093-003	BIPHETAMINE 20	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N010093-007	BIPHETAMINE 12.5	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	Approved before 1982	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Application 010093

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#