Application 078957

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STAVUDINE	STAVUDINE	CAPSULE;ORAL	15MG	No	No
002	STAVUDINE	STAVUDINE	CAPSULE;ORAL	20MG	No	No
003	STAVUDINE	STAVUDINE	CAPSULE;ORAL	30MG	No	No
004	STAVUDINE	STAVUDINE	CAPSULE;ORAL	40MG	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	Approval date
A078957-001	STAVUDINE	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29
A078957-002	STAVUDINE	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29
A078957-003	STAVUDINE	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29
A078957-004	STAVUDINE	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29

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	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078957-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-004	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A078957-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078957-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-004	AB	1	`ea99ee380514…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-515	Stavudine	Stavudine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-516	Stavudine	Stavudine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-517	Stavudine	Stavudine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-518	Stavudine	Stavudine	Camber Pharmaceuticals, Inc.	ANDA	Current
53808-0595	Stavudine	Stavudine	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9204	ORIG	2008-12-31
9203	ORIG	2008-03-04