Application 208612

Type: NDA
Sponsor: AVION PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL	0.02MG;0.1MG	Yes	Yes

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
N208612-001	BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N208612-001	AB3

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208612-001	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	AB3	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	AB3	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208612-001	AB3	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levonorgestrel and ethinyl estradiol	LEVONORGESTREL AND ETHINYL ESTRADIOL	Acella Pharmaceuticals	167b12a0-cdff-4081-a0a4-164482c239fa	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208612 application number: NDA208612 ndc (product): 42192-623
Balcoltra	LEVONORGESTREL AND ETHINYL ESTRADIOL	Avion Pharmaceuticals	752ab698-4b48-4614-8016-d1d33ee7c007	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208612 application number: NDA208612 ndc (product): 75854-602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42192-623	levonorgestrel and ethinyl estradiol	levonorgestrel and ethinyl estradiol	Acella Pharmaceuticals	NDA	Current
75854-602	Balcoltra	levonorgestrel and ethinyl estradiol	Avion Pharmaceuticals	NDA	Current
75854-602	Balcoltra	levonorgestrel and ethinyl estradiol	Avion Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70972	SUPPL	2022-05-04
70953	SUPPL	2022-05-03
56741	ORIG	2018-12-14
51029	ORIG	2018-01-11
51026	ORIG	2018-01-11