Application 077691

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	5MG	No	No
002	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	10MG	No	No
003	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	20MG	No	No
004	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	40MG	No	No
005	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077691-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A077691-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A077691-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A077691-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A077691-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077691-001	AB
A077691-002	AB
A077691-003	AB
A077691-004	AB
A077691-005	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 6 · 220 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
2026-10-15 13:18:30	2026-09	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077691-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077691-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077691-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	AB	1	`b8a1b40f171c…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	A-S Medication Solutions	7fc4df06-48cb-481a-b7b2-d951def683ea	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	d09f88b5-b95f-4315-9b75-c09ce3d94397	2023-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	Proficient Rx LP	b5b47d5b-f953-4e82-99ef-e4e10164095e	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691

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 2 of 2 · 157 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52343-021	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-022	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-022	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-023	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-023	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-024	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-024	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-025	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
52343-025	Simvastatin	Simvastatin	ACETRIS HEALTH, LLC	ANDA	Current
53808-0688	Simvastatin	Simvastatin	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0816	Simvastatin	Simvastatin	State of Florida DOH Central Pharmacy	ANDA	Current
55154-8136	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
55154-8136	Simvastatin	Simvastatin	Cardinal Health 107, LLC	ANDA	Current
55154-8136	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
55154-8136	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
63739-570	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-570	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-570	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-570	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-571	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-571	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-571	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-571	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-572	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-572	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-572	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-572	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-573	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-573	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-573	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-573	Simvastatin	Simvastatin	McKesson Corporation dba SKY Packaging	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-050	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-051	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-052	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-053	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
65862-054	Simvastatin	Simvastatin	Aurobindo Pharma Limited	ANDA	Current
66116-406	Simvastatin	Simvastatin	MedVantx, Inc.	ANDA	Current
66116-408	Simvastatin	Simvastatin	MedVantx, Inc.	ANDA	Current
68071-2336	Simvastatin	Simvastatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2559	Simvastatin	Simvastatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2560	Simvastatin	Simvastatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2628	Simvastatin	Simvastatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9392	Simvastatin	Simvastatin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1282	Simvastatin	Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1282	Simvastatin	Simvastatin	REMEDYREPACK INC.	ANDA	Current
71610-076	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-077	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23883	ORIG	2011-05-26