Azithromycin

Product NDC: 0781-1497
11-digit product format: 007811497
Labeler code: 0781
Product ID: 0781-1497_b6a1cbe0-4765-40fd-b549-2c4dd288abfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065209
Marketing category: ANDA
Marketing start: 2005-11-14
Marketing end: 2020-09-30
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 600 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
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	0781-1497		D	Discontinued by firm	2026-08-03
excluded package	package	0781-1497	0781-1497-01	D	Discontinued by firm	2026-08-03
excluded package	package	0781-1497	0781-1497-31	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	0781-1497-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-1497-01	`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	0781-1497-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-1497-01	`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	0781-1497-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-1497-01	`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	0781-1497-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-1497-01	`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	0781-1497-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-1497-01	`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	0781-1497-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-1497-01	`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	0781-1497-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-1497-01	`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	0781-1497-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-1497-01	`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	0781-1497-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-1497-01	`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	0781-1497-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-1497-01	`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	0781-1497-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-1497-01	`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	0781-1497-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-1497-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A065209-001	AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB		2005-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065209-001	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 · 41 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	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065209-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2005-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065209-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065209-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065209-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065209-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065209-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065209-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065209-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065209-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065209-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065209-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065209-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065209-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065209-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065209-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065209-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065209-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065209-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065209-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065209-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065209-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065209-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065209-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065209-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065209-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065209-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065209-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065209-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065209-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065209-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065209-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065209-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065209-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065209-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065209-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065209-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065209-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065209-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065209-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065209-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065209-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1497-31	EA - Each	0781-1497	49680bd2-74ab-4215-9992-ca848c5ee656	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]	16

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Sandoz Inc	34b70c23-92a6-460f-8dbb-15a0e6b9d3a9	2021-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065209 application number: ANDA065209