Application 074909

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET;ORAL	2MG	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
A074909-001	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB		1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074909-001	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	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`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	A074909-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074909-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074909-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074909-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074909-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074909-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074909-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074909-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074909-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074909-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074909-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074909-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074909-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074909-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074909-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074909-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074909-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074909-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074909-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074909-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074909-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074909-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074909-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074909-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074909-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074909-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074909-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074909-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074909-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074909-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074909-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074909-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074909-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074909-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074909-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074909-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074909-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074909-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074909-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074909-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	3c0cb60f-1c3a-48a6-ad16-f14351548412	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 50090-2819
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 55289-523
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 0781-1089
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	b0000772-2514-45a2-a75d-1bbb13c29989	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 71335-0920
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 63187-444

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
0781-1089	Alprazolam	Alprazolam	Sandoz Inc	ANDA	Current
21695-250	Alprazolam	Alprazolam	Rebel Distributors Corp.	ANDA	Current
50090-2819	Alprazolam	Alprazolam	A-S Medication Solutions	ANDA	Current
55289-523	Alprazolam	Alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-523	Alprazolam	Alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-523	Alprazolam	Alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-523	Alprazolam	Alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-523	Alprazolam	Alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-862	ALPRAZOLAM	ALPRAZOLAM	DIRECT RX	ANDA	Current
63187-444	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
63187-444	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
63187-444	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
66267-564	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-564	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0920	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0920	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0920	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0920	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22381	ORIG	1998-03-25