Ondansetron

Product NDC: 0378-0374
11-digit product format: 003780374
Labeler code: 0378
Product ID: 0378-0374_f80f6db7-f367-4a60-8347-cbb96adb5f34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076930
Marketing category: ANDA
Marketing start: 2007-06-25
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 24 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-0374		D	Discontinued by firm	2026-10-05
excluded package	package	0378-0374	0378-0374-05	D	Discontinued by firm	2026-10-05
excluded package	package	0378-0374	0378-0374-32	D	Discontinued by firm	2026-10-05
excluded package	package	0378-0374	0378-0374-93	D	Discontinued by firm	2026-10-05

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 · 48 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	0378-0374-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0374-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0374-93	`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	0378-0374-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0374-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0374-93	`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	0378-0374-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0374-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0374-93	`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	0378-0374-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0374-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0374-93	`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	0378-0374-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0374-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0374-93	`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	0378-0374-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0374-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0374-93	`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	0378-0374-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0374-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0374-93	`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	0378-0374-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0374-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0374-93	`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	0378-0374-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0374-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0374-93	`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	0378-0374-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0374-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0374-93	`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	0378-0374-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0374-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0374-93	`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	0378-0374-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0374-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0374-93	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076930-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25
A076930-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25
A076930-004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076930-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076930-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076930-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076930-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076930-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076930-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076930-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076930-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE
4AF302ESOS	ONDANSETRON	99614-02-5	ondansetron

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0374-05	00378037405	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-05)	2007-06-25	0000-00-00	No	No	Current
0378-0374-32	00378037432	1 TABLET, FILM COATED in 1 BLISTER PACK (0378-0374-32)	2007-06-25	0000-00-00	No	No	Current
0378-0374-93	00378037493	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-93)	2007-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Mylan Pharmaceuticals Inc. \| Mylan Pharmaceuticals, Inc. \| HOVIONE PHARMASCIENCE LIMITED	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	12