Application 214696

Type: ANDA
Sponsor: MICRO LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	TABLET;ORAL	100MG;25MG	No	No
002	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	TABLET;ORAL	200MG;50MG	No	No

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

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
A214696-001	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET / ORAL	AB		2025-12-11
A214696-002	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET / ORAL	AB		2025-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214696-001	AB
A214696-002	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
2026-09-14 22:38:34	2026-08	A214696-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2025-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214696-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2025-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214696-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2025-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214696-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2025-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214696-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2025-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214696-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2025-12-11	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214696-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2025-12-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214696-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2025-12-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214696-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214696-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214696-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214696-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214696-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214696-002	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214696-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214696-002	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lopinavir and Ritonavir	LOPINAVIR AND RITONAVIR	Macleods Pharmaceuticals Limited	115178c8-5ee2-4d96-820e-ea8264c1ac10	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Lopinavir and Ritonavir
Lopinavir and Ritonavir	LOPINAVIR AND RITONAVIR	Laurus Labs Limited	a7072c60-6dbf-4125-95e7-497c05a9e6a6	2023-10-20	Warnings, Adverse reactions	Name fallback brand name: Lopinavir and Ritonavir
Lopinavir and ritonavir	LOPINAVIR AND RITONAVIR	Camber Pharmaceuticals, Inc.	4e5005b8-f00c-4671-be09-bb927190760f	2021-06-03	Warnings, Adverse reactions	Name fallback brand name: Lopinavir and ritonavir

Reported adverse events (FAERS/openFDA)#

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