Application 085239

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRONE	ESTRONE	INJECTABLE;INJECTION	5MG/ML	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
A085239-001	ESTRONE	ESTRONE	5MG/ML	INJECTABLE / INJECTION		Approved before 1982

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	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A085239-001	ESTRONE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085239-001	ESTRONE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085239-001	ESTRONE	5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`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	Join
Folliculinum	ESTRONE	Boiron	85a11a48-53e6-6616-e053-2991aa0aadf3	2023-11-13	Name fallback generic name: ESTRONE
Folliculinum	ESTRONE	Boiron	83dd22a0-7c59-11e6-84ff-424c58303031	2023-10-23	Name fallback generic name: ESTRONE
Folliculinum	ESTRONE	Boiron	85a0f40f-67a7-16a6-e053-2a91aa0ae640	2023-04-11	Name fallback generic name: ESTRONE
Folliculinum	ESTRONE	Boiron	85a0fad8-8926-6c75-e053-2a91aa0a3b73	2023-01-18	Name fallback generic name: ESTRONE
Folliculinum	ESTRONE	Boiron	862f03b0-d557-4859-e053-2a91aa0a030e	2023-01-06	Name fallback generic name: ESTRONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22666	ORIG	2003-08-04