Application 020412

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZERIT	STAVUDINE	CAPSULE;ORAL	5MG	No	No
002	ZERIT	STAVUDINE	CAPSULE;ORAL	15MG	Yes	No
003	ZERIT	STAVUDINE	CAPSULE;ORAL	20MG	Yes	No
004	ZERIT	STAVUDINE	CAPSULE;ORAL	30MG	Yes	No
005	ZERIT	STAVUDINE	CAPSULE;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020412-001	ZERIT	STAVUDINE	5MG	CAPSULE / ORAL		1994-06-24
N020412-002	ZERIT	STAVUDINE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24
N020412-003	ZERIT	STAVUDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24
N020412-004	ZERIT	STAVUDINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24
N020412-005	ZERIT	STAVUDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24

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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020412-001	ZERIT	5MG	CAPSULE / ORAL		1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020412-002	ZERIT	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020412-003	ZERIT	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020412-004	ZERIT	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020412-005	ZERIT	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-06-24	`03ed91905a0d…`

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	N020412-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020412-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020412-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020412-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020412-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020412-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020412-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020412-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020412-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020412-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020412-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020412-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020412-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020412-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020412-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020412-005	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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-1964	ZERIT	Stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1965	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1965	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1965	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1966	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1966	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1966	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1967	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1967	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-1967	ZERIT	stavudine	E.R. Squibb & Sons, L.L.C.	NDA	Current
53808-0656	ZERIT	stavudine	State of Florida DOH Central Pharmacy	NDA	Current
53808-0657	ZERIT	stavudine	State of Florida DOH Central Pharmacy	NDA	Current
53808-0795	ZERIT	stavudine	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56917	SUPPL	2018-12-21
56777	SUPPL	2018-12-18
56776	SUPPL	2018-12-18
50867	SUPPL	2017-12-27
50820	SUPPL	2017-12-21
34633	SUPPL	2011-11-22
24942	SUPPL	2011-11-22
2513	SUPPL	2011-05-16
2512	SUPPL	2010-12-28
12558	SUPPL	2010-12-23
2511	SUPPL	2009-07-15
34632	SUPPL	2009-07-09
34631	SUPPL	2009-02-20
24941	SUPPL	2009-02-18
34630	SUPPL	2009-01-02
2510	SUPPL	2008-12-18
34629	SUPPL	2008-04-23
12557	SUPPL	2008-04-23
2509	SUPPL	2008-04-16
2508	SUPPL	2008-04-16
2507	SUPPL	2007-06-14
2506	SUPPL	2007-04-25
34628	SUPPL	2007-02-05
34627	SUPPL	2004-06-07
2505	SUPPL	2004-06-07
34626	SUPPL	2003-04-22
12556	SUPPL	2002-03-29
2504	SUPPL	2002-03-29
24940	SUPPL	2002-02-20
24939	SUPPL	2002-02-20