Application 202717

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	TABLET;ORAL	EQ 10MG BASE	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
A202717-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2012-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202717-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202717-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202717-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202717-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202717-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202717-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202717-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202717-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202717-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202717-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202717-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202717-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202717-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202717-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202717-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202717-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202717-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202717-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202717-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202717-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202717-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202717-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202717-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202717-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202717-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202717-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202717-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202717-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202717-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202717-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202717-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202717-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202717-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202717-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202717-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202717-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202717-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202717-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202717-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202717-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202717-001	AB	1	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	Redpharm Drug	2fbdf1be-a37f-879b-e063-6394a90aa20d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	c9ec1996-6a54-4622-b8a6-57dea49f6b35	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 43063-762
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	566a8fd7-fc00-2297-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 68071-4047
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	549f1d1a-81f5-29f5-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 68071-3355
Montelukast Sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	4ba27278-6249-4546-9331-b19302cbf2db	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 71335-0514
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 63187-781
Montelukast Sodium	MONTELUKAST SODIUM	Accord Healthcare Inc.	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	2022-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (product): 16729-119

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
53002-1441	Montelukast Sodium	Montelukast Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1441	Montelukast Sodium	Montelukast Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63629-8106	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8106	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0331	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1599	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1599	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current