Finasteride

Product NDC: 0179-0175
11-digit product format: 001790175
Labeler code: 0179
Product ID: 0179-0175_7bbf4e92-d27f-33af-e053-2991aa0a4ae8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET
Route: ORAL
Labeler: KAISER FOUNDATION HOSPITALS
Application: ANDA090061
Marketing category: ANDA
Marketing start: 2015-05-26
Marketing end: 2020-07-31
Substance: FINASTERIDE
Active strength: 5 mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0179-0175		D	Discontinued by firm		2026-09-14
excluded package	package	0179-0175	0179-0175-88	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0179-0175-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0179-0175-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0179-0175-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0179-0175-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0179-0175-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0179-0175-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0179-0175-88	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0179-0175-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0179-0175-88	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0179-0175-88	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0179-0175-88	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0179-0175-88	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090061-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090061-001	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	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`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	A090061-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090061-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090061-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	AB	1	`f41ea6bd6efb…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FINASTERIDE	ACTIVE INGREDIENT	57GNO57U7G	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
FINASTERIDE	ACTIVE MOIETY	57GNO57U7G	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FINASTERIDE TABLET [KAISER FOUNDATION HOSPITALS]	1

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Major Pharmaceuticals	3272651f-b500-4d5d-9e29-22fcd8e24fcb	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	22161236-6804-4a7f-86cb-cfa20bd1951e	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Preferred Pharmaceuticals, Inc.	9ae38bf5-17d7-4af1-922f-b3edb1e65392	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	REMEDYREPACK INC.	c2875bc7-e811-4860-9131-da06cecc2137	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Legacy Pharmaceutical Packaging, LLC	a3b49681-09b3-4c26-bb57-3dfd598d48b6	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	A-S Medication Solutions	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	AvPAK	800fa54c-c008-ba1e-e053-2a91aa0a2b07	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Camber Pharmaceuticals, Inc.	cc9709ce-2d29-48bd-b46b-3f72114f2527	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Dr Reddys Laboratories Inc	c8ed59a3-c5b2-3156-b781-5e514b79011b	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	A-S Medication Solutions	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	57e73fff-2115-41ad-864b-4652f9fd4545	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Exelan Pharmaceuticals Inc.	1c1bf77c-f99a-44e4-b71e-ce766afa99b6	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061