Application 202635

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPCICON ONE-STEP	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
A202635-001	OPCICON ONE-STEP	LEVONORGESTREL	1.5MG	TABLET / ORAL			2014-09-11

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	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Emergency Contraceptive Levonorgestrel	LEVONORGESTREL	Cardinal Health 110, LLC. DBA Leader	d1e33615-0a98-4223-833d-843c758d9db7	2026-05-06	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 70000-0600
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	f3f2a41a-a9af-4d63-81d8-33181d12af40	2025-07-04	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 51660-999
Levonorgestrel	LEVONORGESTREL	Thirty Madison Inc.	6933ae19-4c8f-49a2-96c5-9cdf37ee5824	2024-12-30	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	5c509934-8c11-4d7f-8506-5971c37cfc22	2024-09-06	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 51660-723
Opcicon One-Step	LEVONORGESTREL	Sun Pharmaceutical Industries, Inc.	b67ca313-561e-471f-baf3-257b7e253c75	2023-01-13	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 62756-718
My Choice TM	LEVONORGESTREL	Proficient Rx LP	165f7270-d050-4e97-b30f-107b96940d84	2022-09-01	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 71205-120
My Choice TM	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	66753300-fb61-4f09-af74-ee498b0bd595	2022-04-21	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 62756-720
AfterPlan	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a	2018-10-26	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 62756-723

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
0536-1142	Levonorgestrel	Levonorgestrel	Rugby Laboratories	ANDA	Current
51660-723	Levonorgestrel	Levonorgestrel	Ohm Laboratories Inc.	ANDA	Current
51660-723	Levonorgestrel	Levonorgestrel	Ohm Laboratories Inc.	ANDA	Current
51660-999	Levonorgestrel	Levonorgestrel	Ohm Laboratories Inc.	ANDA	Current
62756-718	Opcicon One-Step	levonorgestrel	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-720	My Choice TM	levonorgestrel	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
62756-720	My Choice TM	levonorgestrel	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
62756-723	AfterPlan	levonorgestrel	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
68071-4247	My Choice TM	levonorgestrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4247	My Choice TM	levonorgestrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
70000-0600	LEADER Emergency Contraceptive Levonorgestrel	levonorgestrel	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0600	LEADER	levonorgestrel	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
71205-120	My Choice TM	levonorgestrel	Proficient Rx LP	ANDA	Current
71205-120	My Choice TM	levonorgestrel	Proficient Rx LP	ANDA	Current
71205-120	My Choice TM	levonorgestrel	Proficient Rx LP	ANDA	Current
71205-120	My Choice TM	levonorgestrel	Proficient Rx LP	ANDA	Current