Application 203103

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	160MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203103-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01
A203103-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01
A203103-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01
A203103-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203103-001	AB
A203103-002	AB
A203103-003	AB
A203103-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-05-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203103-004	AB	1	`a50c72e98297…`

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 7 · 138 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1cd914b6-b250-4b11-8404-41db3589361e	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	07c3fcab-33fe-4a6a-ba67-2d042190c146	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	49d09308-74b0-4f9a-9c03-37234b5ee3a3	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	1bb6d65a-8264-4fa4-92d4-c4a756ec49ea	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	c751ee54-27b4-4ed7-829a-ced735c41312	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	95a2eacd-b6b7-4e92-ae14-52fbee6c6543	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	63abab85-ec88-4fcf-a8e7-0850e5f797ee	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	554c7446-8407-460e-b157-f860c5afbf12	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Major Pharmaceuticals	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	14957737-4e53-cc6d-e063-6294a90a181e	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	36230aaa-b6e5-4ebb-e063-6294a90ac3b9	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	Pierre Fabre Pharmaceuticals, Inc.	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	d027f39e-7648-44c8-a8dc-b26b4cdd81be	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	03afbc5a-a9dc-e823-e063-6394a90a0cb2	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	42def694-9484-a2ca-e063-6394a90a87d8	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	54154f18-2f15-d247-e063-6294a90a7412	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2c9a6403-5ebf-4348-be02-7ffad5832369	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE