Application 078922

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIDOVUDINE	ZIDOVUDINE	TABLET;ORAL	300MG	No	No

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

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
A078922-001	ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET / ORAL			2008-02-14

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 · 44 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
2022-10-28 04:53 UTC	2022-10	A078922-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	2008-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078922-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	2008-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078922-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	2008-02-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078922-001	ZIDOVUDINE	300MG	TABLET / ORAL		2008-02-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078922-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078922-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078922-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078922-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078922-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078922-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078922-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078922-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078922-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078922-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078922-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078922-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078922-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078922-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078922-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078922-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078922-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078922-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078922-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078922-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078922-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078922-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078922-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078922-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078922-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078922-001	AB	1	`cb3db0bc1861…`

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 brand name: Zidovudine generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	51abd2ce-6be1-412d-b806-5f24935ac5e3	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zidovudine generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zidovudine generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4	2024-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zidovudine generic name: ZIDOVUDINE
Zidovudine	ZIDOVUDINE	Camber Pharmaceuticals, Inc.	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zidovudine 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6106	Zidovudine	zidovudine	Mylan Pharmaceuticals Inc.	ANDA	Current
53808-0878	Zidovudine	zidovudine	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9198	ORIG	2008-02-19