Application 040862

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIMIDONE	PRIMIDONE	TABLET;ORAL	50MG	No	No
002	PRIMIDONE	PRIMIDONE	TABLET;ORAL	250MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040862-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL			2008-10-03
A040862-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL			2008-10-03

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 3 of 3 · 86 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	A040862-001	PRIMIDONE	50MG	TABLET / ORAL	2008-10-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040862-002	PRIMIDONE	250MG	TABLET / ORAL	2008-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040862-001	PRIMIDONE	50MG	TABLET / ORAL	2008-10-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040862-002	PRIMIDONE	250MG	TABLET / ORAL	2008-10-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040862-001	PRIMIDONE	50MG	TABLET / ORAL	2008-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040862-002	PRIMIDONE	250MG	TABLET / ORAL	2008-10-03	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Dr. Reddy's Laboratories Limited	a4f917f4-2aa2-c3ed-071e-232fa0f125e8	2010-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040862 application number: ANDA040862 ndc (product): 55111-477 ndc (product): 55111-476

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
55111-476	Primidone	Primidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-477	Primidone	Primidone	Dr. Reddy's Laboratories Limited	ANDA	Current