Application 018613

Type: NDA
Sponsor: TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OVIDE	MALATHION	LOTION;TOPICAL	0.5%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018613-001	OVIDE	MALATHION	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N018613-001	7977324	2026-08-14		Drug product	2011-08-08
N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	LOTION / TOPICAL		RLD	1982-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018613-001	OVIDE	0.5%	LOTION / TOPICAL		RLD	1982-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018613-001	OVIDE	0.5%	LOTION / TOPICAL	AT	RLD, RS	1982-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018613-001	OVIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	1982-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N018613-001	AT	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018613-001	7977324	2026-08-14		Drug product	2011-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018613-001	7560445	2027-02-01	U-986	Drug substance, Drug product		`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ovide	MALATHION	Sun Pharmaceutical Industries, Inc.	945f46fa-4b79-49fd-a890-477f251e2164	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Ovide generic name: MALATHION
Malathion	MALATHION	Sun Pharmaceutical Industries, Inc.	a0b1444b-f51b-44fd-8f23-2fff49b64bc0	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: MALATHION

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
51672-5276	OVIDE	MALATHION	TARO PHARMACEUTICALS USA, INC.	NDA	Current
51672-5277	MALATHION	MALATHION	TARO PHARMACEUTICALS U.S.A., INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11250	SUPPL	2011-12-14
973	SUPPL	2011-12-14
15048	SUPPL	2003-04-16
11249	SUPPL	2003-04-04
20135	SUPPL	1999-04-30
20134	SUPPL	1999-04-30