Application 202058

Type: ANDA
Sponsor: HEC PHARM

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 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
A202058-001	ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET / ORAL			2011-10-07

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	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A202058-001	ZIDOVUDINE	300MG	TABLET / ORAL	2011-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202058-001	ZIDOVUDINE	300MG	TABLET / ORAL	2011-10-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202058-001	ZIDOVUDINE	300MG	TABLET / ORAL	2011-10-07	`a50c72e98297…`

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
0527-1905	Zidovudine	Zidovudine	Lannett Company, Inc.	ANDA	Current
0527-1905	Zidovudine	Zidovudine	Lannett Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32164	ORIG	2011-10-12