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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	AB	2008-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	AB	2008-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	AB	2008-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	AB	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL		2008-12-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL		2008-12-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL		2008-12-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL		2008-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	AB	2008-12-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	AB	2008-12-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	AB	2008-12-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	AB	2008-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078957-001	STAVUDINE	15MG	CAPSULE / ORAL	AB	2008-12-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-002	STAVUDINE	20MG	CAPSULE / ORAL	AB	2008-12-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-003	STAVUDINE	30MG	CAPSULE / ORAL	AB	2008-12-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078957-004	STAVUDINE	40MG	CAPSULE / ORAL	AB	2008-12-29	`ea99ee380514…`

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