Application 091634

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALYACEN 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	TABLET;ORAL-28	0.035MG;1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091634-001	ALYACEN 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET / ORAL-28	AB		2012-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091634-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091634-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091634-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091634-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091634-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091634-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091634-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091634-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091634-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091634-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091634-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091634-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091634-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091634-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091634-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091634-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091634-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091634-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091634-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091634-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091634-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091634-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091634-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091634-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091634-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091634-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091634-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091634-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091634-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091634-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091634-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091634-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091634-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091634-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091634-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091634-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091634-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091634-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091634-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091634-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091634-001	AB	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	Glenmark Pharmaceuticals Inc., USA	5c02b4d3-1e2f-439a-ae45-02304ee190d1	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634 ndc (product): 68462-394
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	Proficient Rx LP	fa32e05b-c86d-4743-aee5-be3fc515152b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634 ndc (product): 71205-547
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	A-S Medication Solutions	a45ee86e-69ca-49a5-8990-5dde52d4a522	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634 ndc (product): 50090-1477

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1477	ALYACEN 1/35	norethindrone and ethinyl estradiol	A-S Medication Solutions	ANDA	Current
50090-1477	ALYACEN 1/35	norethindrone and ethinyl estradiol	A-S Medication Solutions	ANDA	Current
53002-1780	ALYACEN 1/35	norethindrone and ethinyl estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
68462-394	ALYACEN 1/35	norethindrone and ethinyl estradiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-1212	ALYACEN 1/35	norethindrone and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
71205-547	ALYACEN 1/35	norethindrone and ethinyl estradiol	Proficient Rx LP	ANDA	Current