Application 021998

Type: NDA
Sponsor: FDN CONSUMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLAN B ONE-STEP	LEVONORGESTREL	TABLET;ORAL	1.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021998-001	PLAN B ONE-STEP	LEVONORGESTREL	1.5MG	TABLET / ORAL		RLD, RS	2009-07-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plan B One-Step	LEVONORGESTREL	A-S Medication Solutions	fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064	2023-10-24	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998 ndc (product): 50090-5978
Next Choice One Dose	LEVONORGESTREL	Foundation Consumer Healthcare LLC	504735bd-6af9-4588-bf85-d09dbf2a7e41	2023-02-02	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998 ndc (product): 69536-133
Take Action	LEVONORGESTREL	Foundation Consumer Healthcare LLC	78eee7c9-5ca5-45af-898f-92a2f3b2598e	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998 ndc (product): 69536-200
Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	53ad8dff-9134-475c-90b3-8087753e17c4	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998 ndc (product): 69536-103
Plan B One-Step	LEVONORGESTREL	Foundation Consumer Healthcare LLC	6ce6b40e-14ac-47bd-a648-ddf9e452e559	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998 ndc (product): 69536-146 ndc (product): 69536-162

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-973	Plan B One-Step	levonorgestrel	Rebel Distributors Corp	NDA	Current
50090-1141	Plan B One-Step	Levonorgestrel	A-S Medication Solutions	NDA	Current
50090-1141	Plan B One-Step	Levonorgestrel	A-S Medication Solutions	NDA	Current
50090-3830	Plan B One-Step	levonorgestrel	A-S Medication Solutions	NDA	Current
50090-3830	Plan B One-Step	levonorgestrel	A-S Medication Solutions	NDA	Current
50090-5978	Plan B One-Step	levonorgestrel	A-S Medication Solutions	NDA	Current
51285-100	Take Action	Levonorgestrel	Teva Women's Health, Inc.	NDA AUTHORIZED GENERIC	Current
51285-103	Aftera	levonorgestrel	Teva Women's Health, Inc.	NDA AUTHORIZED GENERIC	Current
51285-103	Aftera	levonorgestrel	Teva Women's Health, Inc.	NDA AUTHORIZED GENERIC	Current
51285-146	Plan B One-Step	Levonorgestrel	Teva Women's Health, Inc.	NDA	Current
51285-162	Plan B One-Step	Levonorgestrel	Teva Women's Health, Inc.	NDA	Current
68071-4126	Levonorgestrel	Levonorgestrel	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
69536-103	Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-103	Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-103	Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-133	Next Choice One Dose	levonorgestrel	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-146	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-146	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-146	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-162	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-162	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-162	Plan B One-Step	levonorgestrel	Foundation Consumer Healthcare LLC	NDA	Current
69536-200	Take Action	levonorgestrel	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-200	Take Action	levonorgestrel	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
69536-200	Take Action	levonorgestrel	Foundation Consumer Healthcare LLC	NDA AUTHORIZED GENERIC	Current
76413-323	Plan B One-Step	Levonorgestrel	Central Texas Community Health Centers	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73035	SUPPL	2022-12-23
73034	SUPPL	2022-12-23
73032	SUPPL	2022-12-23
57408	SUPPL	2019-02-04
57138	SUPPL	2019-01-08
49414	SUPPL	2017-08-15
49413	SUPPL	2017-08-15
42378	SUPPL	2015-11-17
38048	SUPPL	2013-09-24
6645	SUPPL	2013-06-24
16725	SUPPL	2013-06-21
6644	SUPPL	2013-05-02
42377	ORIG	2009-11-24
24230	ORIG	2009-11-24
38047	ORIG	2009-07-13
29024	ORIG	2009-07-13
53321	ORIG	1900-01-01
53320	ORIG	1900-01-01
53319	ORIG	1900-01-01
53318	ORIG	1900-01-01
53317	ORIG	1900-01-01