Application 011641

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	DIABINESE	CHLORPROPAMIDE	TABLET;ORAL	100MG	Yes	No
006	DIABINESE	CHLORPROPAMIDE	TABLET;ORAL	250MG	Yes	No

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

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
N011641-003	DIABINESE	CHLORPROPAMIDE	100MG	TABLET / ORAL		RLD, Approved before 1982
N011641-006	DIABINESE	CHLORPROPAMIDE	250MG	TABLET / ORAL		RLD, 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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N011641-003	DIABINESE	100MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N011641-006	DIABINESE	250MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011641-003	DIABINESE	100MG	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N011641-006	DIABINESE	250MG	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011641-003	DIABINESE	100MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011641-006	DIABINESE	250MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011641-003	DIABINESE	100MG	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011641-006	DIABINESE	250MG	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`

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
20028	SUPPL	2011-10-10
11943	SUPPL	2011-02-04
10769	SUPPL	2011-02-04
10768	SUPPL	2009-09-17
33050	SUPPL	2008-11-07
277	SUPPL	2008-10-29
20027	SUPPL	2007-07-06
40674	SUPPL	2006-10-26
40673	SUPPL	2006-10-26
276	SUPPL	2004-01-09
275	SUPPL	2002-05-16
274	SUPPL	2002-05-16