Amoxicillin and Clavulanate potassium

Product NDC: 69097-098
Requested package NDC: 69097-098-08
11-digit product format: 690970098
Labeler code: 69097
Product ID: 69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: SUSPENSION
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA065431
Marketing category: ANDA
Marketing start: 2024-10-28
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250; 62.5 mg/5mL; mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2008-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065431-001	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	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065431-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-11-25	`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	A065431-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065431-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065431-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065431-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065431-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065431-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065431-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065431-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065431-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065431-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065431-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065431-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065431-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065431-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065431-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065431-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065431-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065431-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065431-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065431-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065431-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065431-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065431-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065431-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065431-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065431-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065431-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065431-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065431-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065431-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065431-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065431-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065431-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065431-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065431-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065431-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065431-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065431-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065431-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065431-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	250 mg/5mL
CLAVULANATE POTASSIUM	62.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup
Q42OMW3AT8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617322	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
db25500a-90ee-429f-991f-da511cec7882	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69097-098-08	Amoxicillin and Clavulanate potassium	150 mL in 1 BOTTLE	SUSPENSION	150	2
69097-098-43	Amoxicillin and Clavulanate potassium	75 mL in 1 BOTTLE	SUSPENSION	75	2
69097-098-44	Amoxicillin and Clavulanate potassium	100 mL in 1 BOTTLE	SUSPENSION	100	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-098-08	ML - Milliliter	69097-098	02ec44d8-7ec4-4643-99dc-e3fe0765973f	1	2025-01-14
69097-098-43	ML - Milliliter	69097-098	529a632b-84d3-4e2a-84df-d310c996e94e	1	2025-01-14
69097-098-44	ML - Milliliter	69097-098	d8fe9eb6-be7d-4d48-aa83-009a787b850a	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-098	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [CIPLA USA INC.]	2	Current NDC, 3 package rows	20241029_db25500a-90ee-429f-991f-da511cec7882.zip

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
Amoxicillin and Clavulanate potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Cipla USA Inc.	db25500a-90ee-429f-991f-da511cec7882	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065431 application number: ANDA065431 ndc (package): 69097-098-08 ndc (product): 69097-098 ndc11 (package): 69097009808

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617322	amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension	PSN	db25500a-90ee-429f-991f-da511cec7882	2
617322	amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension	SCD	db25500a-90ee-429f-991f-da511cec7882	2
617322	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension	SY	db25500a-90ee-429f-991f-da511cec7882	2
617322	amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral Suspension	SY	db25500a-90ee-429f-991f-da511cec7882	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69097-098-08	69097009808	150 mL in 1 BOTTLE (69097-098-08)	150 ml	2024-10-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate potassium	Cipla USA Inc. \| Cipla Limited \| MEDISPRAY LABORATORIES PRIVATE LIMITED	2024-10-28	HUMAN PRESCRIPTION DRUG LABEL	2