Tirofiban

Product NDC: 55150-429
Requested package NDC: 55150-429-01
11-digit product format: 551500429
Labeler code: 55150
Product ID: 55150-429_1751523a-e22e-4faf-bdb1-c850afe2fd36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tirofiban
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA216379
Marketing category: ANDA
Marketing start: 2023-05-01
Substance: TIROFIBAN HYDROCHLORIDE
Active strength: 5 mg/100mL
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216379-001	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-05-01
A216379-002	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216379-001	AP
A216379-002	AP

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 · 44 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	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216379-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216379-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-05-01	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A216379-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216379-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216379-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216379-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216379-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216379-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216379-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216379-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216379-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216379-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216379-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216379-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216379-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216379-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216379-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216379-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216379-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216379-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216379-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216379-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216379-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216379-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216379-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216379-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216379-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216379-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216379-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216379-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216379-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216379-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216379-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216379-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216379-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216379-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216379-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216379-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216379-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216379-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216379-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216379-002	AP	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tirofiban
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIROFIBAN HYDROCHLORIDE	5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6H925F8O5J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737466	Internal RxNorm lookup
1737471	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
d554acff-22e9-4f28-b826-ee1b91daa2df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3502f65-b30c-cd90-0b5d-36be3bd715c1	Product name	3	20240507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-429-01	Tirofiban	1 in 1 POUCH	INJECTION, SOLUTION	1		2
55150-429-01	Tirofiban	1 in 1 CARTON	INJECTION, SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-429-01	ML - Milliliter	55150-429	98cd7a2c-5689-474c-b3ef-77173dcae4e0	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-429	TIROFIBAN INJECTION, SOLUTION [EUGIA US LLC]	2	Current NDC, 2 package rows	20230714_d554acff-22e9-4f28-b826-ee1b91daa2df.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
Tirofiban	TIROFIBAN	Eugia US LLC	d554acff-22e9-4f28-b826-ee1b91daa2df	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216379 application number: ANDA216379 ndc (package): 55150-429-01 ndc (product): 55150-429 ndc11 (package): 55150042901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6H925F8O5J	TIROFIBAN HYDROCHLORIDE	150915-40-5	TIROFIBAN HYDROCHLORIDE
GGX234SI5H	TIROFIBAN	144494-65-5	Tirofiban

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737471	tirofiban 12.5 MG in 250 ML Injection	PSN	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737466	tirofiban 5 MG in 100 ML Injection	PSN	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737466	100 ML tirofiban 0.05 MG/ML Injection	SCD	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737471	250 ML tirofiban 0.05 MG/ML Injection	SCD	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737471	tirofiban (as hydrochloride) 12.5 MG per 250 ML Injection	SY	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737466	tirofiban (as hydrochloride) 5 MG per 100 ML Injection	SY	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737471	tirofiban 12.5 MG per 250 ML Injection	SY	d554acff-22e9-4f28-b826-ee1b91daa2df	2
1737466	tirofiban 50 MCG per 1 ML Injection	SY	d554acff-22e9-4f28-b826-ee1b91daa2df	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55150-429-01	55150042901	1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	1 pouch	2023-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tirofiban	Eugia US LLC \| Eugia Pharma Specialities Limited	2023-07-13	Human Prescription Drug Label	2