Application 206867

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATHENTIA NEXT	LEVONORGESTREL	TABLET;ORAL	1.5MG	No	No

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
A206867-001	ATHENTIA NEXT	LEVONORGESTREL	1.5MG	TABLET / ORAL			2015-12-08

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206867-001	ATHENTIA NEXT	1.5MG	TABLET / ORAL	2015-12-08	`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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levonorgestrel	LEVONORGESTREL	Rugby Laboratories	076126e4-9d76-45cd-a86b-5b35c56b620a	2026-05-13	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Julie Morning After Pill	LEVONORGESTREL	Julie Products Inc.	40bb96f0-d5f1-1ec3-e063-6294a90a74b1	2025-11-26	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Julie Morning After Pill	LEVONORGESTREL	Julie Products Inc.	40bbad6f-0c54-e4ed-e063-6394a90af3ad	2025-11-14	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
EContra One-Step	LEVONORGESTREL	Afaxys Pharma, LLC	94b23c49-dfba-4a70-ada5-e5c212e703c5	2025-04-08	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 50102-211
Julie	LEVONORGESTREL	Julie Products Inc.	8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae8	2025-04-07	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 82791-538
ITHAPPENZ MORNING AFTER	LEVONORGESTREL	Aurohealth LLC	5ee40793-0121-4b8f-b20d-3178bbe262e2	2025-04-07	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Julie	LEVONORGESTREL	Julie Products Inc.	8d20510f-a4e8-4d4b-a96a-f0da91785833	2025-04-07	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 82791-532
Econ Morning After	LEVONORGESTREL	Aurohealth LLC	177daa65-2e7d-4ff4-887e-b927d6ed8825	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 58602-841
Levonorgestrel	LEVONORGESTREL	LEADER/ CARDINAL HEALTH 110, INC.	c7d3a74e-37c4-4c49-861c-64ef363d5a53	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Fem Choice morning after	LEVONORGESTREL	Aurohealth LLC	14051537-9d6c-4f73-a6e9-5eed554bbf65	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 58602-712
AMAZON BASIC CARE LEVONORGESTREL	LEVONORGESTREL	Amazon.com Services LLC	10ecae6f-386f-e199-e063-6294a90a680b	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Athentia Next	LEVONORGESTREL	Aurohealth LLC	34e5aa53-3943-4e2f-93aa-b5a4d779a703	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 58602-721
After Banger	LEVONORGESTREL	Aurohealth LLC	791a2461-971c-4191-8905-5a449c600a49	2025-04-04	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867
Morning After	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	677aa953-3c30-4ce5-e053-2991aa0ab2b2	2018-03-15	Warnings	Exact identifier application applno (ANDA): 206867 application number: ANDA206867 ndc (product): 69953-515

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50102-211	EContra One-Step	Levonorgestrel	Afaxys Pharma, LLC	ANDA	Current
50102-211	EContra One-Step	Levonorgestrel	Afaxys Pharma, LLC	ANDA	Current
50102-211	EContra One-Step	Levonorgestrel	Afaxys Pharma, LLC	ANDA	Current
50102-211	EContra One-Step	Levonorgestrel	Afaxys Pharma, LLC	ANDA	Current
58602-712	Fem Choice morning after	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-712	Fem Choice morning after	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-721	Athentia Next	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-721	Athentia Next	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-721	Athentia Next	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-841	Econ Morning After	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-841	Econ Morning After	Levonorgestrel	Aurohealth LLC	ANDA	Current
58602-841	Econ Morning After	Levonorgestrel	Aurohealth LLC	ANDA	Current
69953-515	Morning After	Levonorgestrel	Rapha Pharmaceuticals, Inc.	ANDA	Current
69953-616	PostDay One-Step	Levonorgestrel	Rapha Pharmaceuticals, Inc.	ANDA	Current
82791-532	Julie	Levonorgestrel	Julie Products Inc.	ANDA	Current
82791-538	Julie	Levonorgestrel	Julie Products Inc.	ANDA	Current