Application 019655

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETROVIR	ZIDOVUDINE	CAPSULE;ORAL	100MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019655-001	RETROVIR	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	RLD, RS	1987-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019655-001	AB

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 2 · 43 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
2022-09-29 23:25 UTC	2022-09	N019655-001	RETROVIR	100MG	CAPSULE / ORAL	AB	RLD, RS	1987-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019655-001	RETROVIR	100MG	CAPSULE / ORAL	AB	RLD, RS	1987-03-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019655-001	RETROVIR	100MG	CAPSULE / ORAL	AB	RLD, RS	1987-03-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019655-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019655-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019655-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019655-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019655-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019655-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019655-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019655-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019655-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019655-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019655-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019655-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019655-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019655-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019655-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019655-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019655-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019655-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019655-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019655-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019655-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019655-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019655-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019655-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019655-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019655-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019655-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019655-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019655-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019655-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019655-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019655-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019655-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019655-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019655-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019655-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019655-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019655-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zidovudine	ZIDOVUDINE	Coupler LLC	437f55b2-f6d9-0065-e063-6294a90ab929	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	51abd2ce-6be1-412d-b806-5f24935ac5e3	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4	2024-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Camber Pharmaceuticals, Inc.	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIDOVUDINE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80703	SUPPL	2024-12-23
80649	SUPPL	2024-12-19
65919	SUPPL	2021-01-19
63636	SUPPL	2020-06-19
55435	SUPPL	2018-09-12
55424	SUPPL	2018-09-11
50553	SUPPL	2017-12-01
50526	SUPPL	2017-11-29
48021	SUPPL	2017-04-14
48005	SUPPL	2017-04-13
47438	SUPPL	2017-03-03
47365	SUPPL	2017-02-28
33845	SUPPL	2015-01-08
17530	SUPPL	2014-12-31
33844	SUPPL	2012-06-06
17529	SUPPL	2012-06-04
1469	SUPPL	2011-12-01
11609	SUPPL	2011-11-25
1468	SUPPL	2010-05-21
11608	SUPPL	2010-05-18
17528	SUPPL	2010-01-06
33843	SUPPL	2009-11-23
11607	SUPPL	2008-09-25
17527	SUPPL	2008-09-23
17526	SUPPL	2006-11-22
33842	SUPPL	2006-11-16
17525	SUPPL	2006-05-18
11606	SUPPL	2006-05-16
40959	SUPPL	2005-04-19
33841	SUPPL	2003-10-17
17524	SUPPL	2003-10-17
11605	SUPPL	2003-06-16
33840	SUPPL	2003-04-04
17523	SUPPL	2002-12-18
1467	SUPPL	2002-02-21
33839	SUPPL	2001-03-30
1466	SUPPL	2001-03-30