Application 020705

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RESCRIPTOR	DELAVIRDINE MESYLATE	TABLET;ORAL	100MG	Yes	No
002	RESCRIPTOR	DELAVIRDINE MESYLATE	TABLET;ORAL	200MG	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
N020705-001	RESCRIPTOR	DELAVIRDINE MESYLATE	100MG	TABLET / ORAL		RLD	1997-04-04
N020705-002	RESCRIPTOR	DELAVIRDINE MESYLATE	200MG	TABLET / ORAL		RLD	1999-07-14

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020705-001	RESCRIPTOR	100MG	TABLET / ORAL	RLD	1997-04-04	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020705-002	RESCRIPTOR	200MG	TABLET / ORAL	RLD	1999-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020705-001	RESCRIPTOR	100MG	TABLET / ORAL	RLD	1997-04-04	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020705-002	RESCRIPTOR	200MG	TABLET / ORAL	RLD	1999-07-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020705-001	RESCRIPTOR	100MG	TABLET / ORAL	RLD	1997-04-04	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020705-002	RESCRIPTOR	200MG	TABLET / ORAL	RLD	1999-07-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020705-001	RESCRIPTOR	100MG	TABLET / ORAL	RLD	1997-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020705-002	RESCRIPTOR	200MG	TABLET / ORAL	RLD	1999-07-14	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020705-002	6177101	2019-06-07	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020705-002	6177101	2019-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020705-002	6177101	2019-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020705-002	6177101	2019-06-07	`ea99ee380514…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-209	RESCRIPTOR	delavirdine mesylate	ViiV Healthcare Company	NDA	Current
49702-225	RESCRIPTOR	delavirdine mesylate	ViiV Healthcare Company	NDA	Current
49702-225	RESCRIPTOR	delavirdine mesylate	ViiV Healthcare Company	NDA	Current
49702-225	RESCRIPTOR	delavirdine mesylate	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13253	SUPPL	2012-08-15
3142	SUPPL	2012-08-15
41593	SUPPL	2007-07-09
20862	SUPPL	2007-07-09
20861	SUPPL	2007-07-09
20860	SUPPL	2007-07-09
3141	SUPPL	2006-04-13
41592	SUPPL	2004-03-24
13252	SUPPL	2003-04-22
3140	SUPPL	2002-03-14
25581	SUPPL	1999-07-14
13251	SUPPL	1999-07-14