Application 205329

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVONORGESTREL	LEVONORGESTREL	TABLET;ORAL	1.5MG	No	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
A205329-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2018-09-18

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205329-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2018-09-18	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PostDay One-Step	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	6f7f5697-acb6-ea95-e053-2991aa0ae7c7	2023-11-21	Warnings	Exact identifier application applno (ANDA): 205329 application number: ANDA205329
Levonorgestrel	LEVONORGESTREL	Xiromed LLC	626a2333-ff56-ef28-a287-b33bacc0302a	2023-09-05	Warnings	Exact identifier application applno (ANDA): 205329 application number: ANDA205329 ndc (product): 70700-164
Emergency Contraceptive	LEVONORGESTREL	P & L Development, LLC	25676fc2-1f1f-40d2-8e84-3e52c8abda49	2023-06-27	Warnings	Exact identifier application applno (ANDA): 205329 application number: ANDA205329
Morning After	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	f0fab784-3d28-35fb-e053-2995a90ab611	2022-12-29	Warnings	Exact identifier application applno (ANDA): 205329 application number: ANDA205329 ndc (product): 69953-516 ndc (product): 69953-517

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
69953-516	Morning After	Levonorgestrel	Rapha Pharmaceuticals, Inc.	ANDA	Current
69953-517	Morning After	Levonorgestrel	Rapha Pharmaceuticals, Inc.	ANDA	Current
70700-164	Levonorgestrel	Levonorgestrel	Xiromed LLC	ANDA	Current
70700-164	Levonorgestrel	Levonorgestrel	Xiromed LLC	ANDA	Current