Tamoxifen Citrate

Product NDC: 51862-449
11-digit product format: 518620449
Labeler code: 51862
Product ID: 51862-449_119f75fc-b5e9-4a34-93d1-99ac302ac545
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamoxifen Citrate
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA070929
Marketing category: ANDA
Marketing start: 2016-07-18
Marketing end: 2019-07-31
Substance: TAMOXIFEN CITRATE
Active strength: 10 mg/1
Pharmacologic classes: Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51862-449		D	Discontinued by firm	2026-08-03
excluded package	package	51862-449	51862-449-18	D	Discontinued by firm	2026-08-03
excluded package	package	51862-449	51862-449-60	D	Discontinued by firm	2026-08-03

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 · 36 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	51862-449-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-449-60	`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	51862-449-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-449-60	`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	51862-449-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-449-60	`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	51862-449-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-449-60	`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	51862-449-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-449-60	`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	51862-449-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-449-60	`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	51862-449-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-449-60	`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	51862-449-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-449-60	`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	51862-449-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-449-60	`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	51862-449-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-449-60	`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	51862-449-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-449-60	`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	51862-449-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51862-449-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070929-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20
A070929-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2003-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A070929-001	AB
A070929-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-449-18	EA - Each	51862-449	cf8e3d01-89d0-4e0a-a253-01ff67421566	1	2016-09-02

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	8c0eb763-420a-4106-ba56-526b53a7f72b	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	8d731e7e-3b04-49a2-a0f6-3779422174cc	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	Actavis Pharma, Inc.	9b8a4211-120f-4981-ad69-928accb97637	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	716657e8-d809-4671-87bc-8d10ef69a071	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals,Inc.	a5615dbb-3c5e-6ccc-e053-2995a90ab698	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	Proficient Rx LP	bb53eeb7-83fc-469e-b9e3-df5f27bfec7b	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929