Application 021045

Type: NDA
Sponsor: FDN CONSUMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLAN B	LEVONORGESTREL	TABLET;ORAL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PLAN B	LEVONORGESTREL	TABLET;ORAL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N021045-001	PLAN B	LEVONORGESTREL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1999-07-28
N021045-002	PLAN B	LEVONORGESTREL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-08-24

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021045-001	PLAN B	0.75MG	TABLET / ORAL	RLD	1999-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021045-002	PLAN B	0.75MG	TABLET / ORAL	RLD	2006-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021045-001	PLAN B	0.75MG	TABLET / ORAL	RLD	1999-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021045-002	PLAN B	0.75MG	TABLET / ORAL	RLD	2006-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021045-001	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021045-002	PLAN B	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2006-08-24	`74a2ff9319b5…`

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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AfterPill	LEVONORGESTREL	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1	2025-05-01	Warnings	Name fallback generic name: LEVONORGESTREL
PostDay One-Step	LEVONORGESTREL	Home Health Brands, LLC	01c8c95c-6fbe-4068-915d-74418a6bb570	2025-04-23	Warnings	Name fallback generic name: LEVONORGESTREL
Morning After Pill	LEVONORGESTREL	Cadence Health Inc	2fb59f53-d885-9d4a-e063-6394a90a88cc	2025-04-15	Warnings	Name fallback generic name: LEVONORGESTREL
EContra One-Step	LEVONORGESTREL	Afaxys Pharma, LLC	94b23c49-dfba-4a70-ada5-e5c212e703c5	2025-04-08	Warnings	Name fallback generic name: LEVONORGESTREL
Julie	LEVONORGESTREL	Julie Products Inc.	8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae8	2025-04-07	Warnings	Name fallback generic name: LEVONORGESTREL
ITHAPPENZ MORNING AFTER	LEVONORGESTREL	Aurohealth LLC	5ee40793-0121-4b8f-b20d-3178bbe262e2	2025-04-07	Warnings	Name fallback generic name: LEVONORGESTREL
Julie	LEVONORGESTREL	Julie Products Inc.	8d20510f-a4e8-4d4b-a96a-f0da91785833	2025-04-07	Warnings	Name fallback generic name: LEVONORGESTREL
Econ Morning After	LEVONORGESTREL	Aurohealth LLC	177daa65-2e7d-4ff4-887e-b927d6ed8825	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	LEADER/ CARDINAL HEALTH 110, INC.	c7d3a74e-37c4-4c49-861c-64ef363d5a53	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
Fem Choice morning after	LEVONORGESTREL	Aurohealth LLC	14051537-9d6c-4f73-a6e9-5eed554bbf65	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
AMAZON BASIC CARE LEVONORGESTREL	LEVONORGESTREL	Amazon.com Services LLC	10ecae6f-386f-e199-e063-6294a90a680b	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
Athentia Next	LEVONORGESTREL	Aurohealth LLC	34e5aa53-3943-4e2f-93aa-b5a4d779a703	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
After Banger	LEVONORGESTREL	Aurohealth LLC	791a2461-971c-4191-8905-5a449c600a49	2025-04-04	Warnings	Name fallback generic name: LEVONORGESTREL
Morning After Pill	LEVONORGESTREL	Cadence Health Inc	fc5d29bb-4a4b-e61e-e053-6394a90a8a62	2025-02-14	Warnings	Name fallback generic name: LEVONORGESTREL
My Way	LEVONORGESTREL	Proficient Rx LP	f2354b0c-dda4-4eb4-93f3-b2d57856a948	2025-01-01	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Thirty Madison Inc.	6933ae19-4c8f-49a2-96c5-9cdf37ee5824	2024-12-30	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	5c509934-8c11-4d7f-8506-5971c37cfc22	2024-09-06	Warnings	Name fallback generic name: LEVONORGESTREL
My Way	LEVONORGESTREL	NuCare Pharmaceuticals,Inc.	6598a875-8be8-0928-e053-2a91aa0a064d	2024-06-06	Warnings	Name fallback generic name: LEVONORGESTREL
PostDay One-Step	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	6f7f5697-acb6-ea95-e053-2991aa0ae7c7	2023-11-21	Warnings	Name fallback generic name: LEVONORGESTREL
Plan B One-Step	LEVONORGESTREL	A-S Medication Solutions	fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064	2023-10-24	Warnings	Name fallback generic name: LEVONORGESTREL

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
77914	SUPPL	2024-03-22
77913	SUPPL	2024-03-22
54006	SUPPL	2018-05-03
53863	SUPPL	2018-04-27
49897	SUPPL	2017-09-29
49883	SUPPL	2017-09-29
4156	SUPPL	2009-11-20
35975	SUPPL	2009-08-14
21387	SUPPL	2006-08-29
35974	SUPPL	2006-08-24
4155	SUPPL	2006-08-24
44090	ORIG	2006-08-23
41902	ORIG	1999-07-28
26587	ORIG	1999-07-28
14244	ORIG	1999-07-28