Application 091677

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPINAVIR; RITONAVIR	LOPINAVIR; RITONAVIR	TABLET; ORAL	200MG; 50MG	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
A091677-001	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET / ORAL	AB		2021-06-04
A091677-002	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET / ORAL	AB		2021-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091677-001	AB
A091677-002	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.

Product history page 1 of 2 · 70 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
2026-09-14 22:38:34	2026-08	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091677-001	LOPINAVIR AND RITONAVIR	100MG;25MG	TABLET / ORAL	AB	2021-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091677-002	LOPINAVIR AND RITONAVIR	200MG;50MG	TABLET / ORAL	AB	2021-06-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091677-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091677-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091677-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091677-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091677-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091677-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091677-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091677-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091677-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091677-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091677-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091677-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091677-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091677-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091677-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091677-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091677-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091677-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091677-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091677-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091677-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091677-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091677-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091677-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091677-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091677-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091677-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091677-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091677-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091677-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091677-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091677-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091677-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091677-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091677-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091677-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091677-002	AB	1	`bb7c543d1eb4…`

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
Lopinavir and ritonavir	LOPINAVIR AND RITONAVIR	Camber Pharmaceuticals, Inc.	4e5005b8-f00c-4671-be09-bb927190760f	2021-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091677 application number: ANDA091677 ndc (product): 31722-603 ndc (product): 31722-556

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-556	Lopinavir and ritonavir	Lopinavir and ritonavir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-603	Lopinavir and ritonavir	Lopinavir and ritonavir	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31545	ORIG	2012-05-24